clinical research associate training germany

Free Shipping

Secure Payment

easy returns

24/7 support

CRA-Basic-Training

275,00  € zzgl. 19 % USt.

Choose Our Clinical Research Associate Training for Your Learning Needs: A Training that Comprises of Everything You Need to Know for Successful Clinical Monitoring

Our comprehensive CRA Basic Training provides an opportunity for you to play a crucial role in the development of new medications, treatments, and medical devices. Within clinical trials, CRAs secure that the necessary expertise, compliance, and efficiency is applied to the field of clinical research and monitoring. This course prepares participants to learn and apply these skills and to handle various challenges that may arise during clinical research. Thus, making participants more efficient in their roles.

This training includes fundamental knowledge of regulations, four modules on efficient clinical monitoring, and a practical exercise so that participants get familiarized with theory and its application in an effective manner.

The demand for qualified CRAs is growing rapidly in the pharmaceutical, biotechnology, and medical device industries. Completing CRA training enhances your employability by demonstrating your commitment to the field and equipping you with the necessary skills and knowledge sought by employers.

Sign up for this Clinical Research Associate training and learn all you need to know to make a lasting impact in the field of clinical research!

• Description
• Reviews (0)

Content and Objective of the Course

One of the most important and impactful tools of quality control in clinical studies is Clinical Monitoring. Clinical Monitoring is performed by clinical monitors or Clinical Research Associates (CRAs). Given how crucial clinical monitoring is to clinical research, there are a lot of career prospects in this field. There is a constant need to train people with a scientific and/or pharmaceutical background to become CRAs. However, being a CRA entails more than simply comprehending science and medicine. It also calls for a fundamental knowledge of regulations, the law, and finances. Soft skills like the handling of complex social interactions and cultural differences, time management, and communication skills are also important for a successful career as a CRA.

We recommend participating in this training to everyone with a scientific or pharmaceutical background who has an interest in the field of clinical research and monitoring to get an actual and thorough overview of your workplace as a CRA. This training was created by experts with more than 17 years of experience in clinical research, clinical monitoring, and project management. It covers a lot of useful information that CRAs should be familiar with and utilize on a regular basis. All topics are explained in detail and supported by exercises and questions. Anyone who wants to learn more about what a monitor does prior to, during, and following a clinical study is advised to attend the CRA-Basic-Training. We suggest doing our GCP-Basic-Training and ISO14155-Basic-Training in addition to the CRA-Basic-Training if you would also like to gain a general understanding of the legal requirements of a clinical trial.

Instructions for Participants and General Conditions

The online training consists of five modules, each lasting approximately 60 minutes:

• Efficient Clinical Monitoring – Start-up Phase – Part 1
• Efficient Clinical Monitoring – Start-up Phase – Part 2
• Efficient Clinical Monitoring – During and After the Study – Part 1
• Practical Exercise: The Source Data Verification
• Efficient Clinical Monitoring – During and After the Study – Part 2

The modules are continuously updated to the most current legal regulations and trends (no liability assumed). Each module consists of a presentation of approximately 60 minutes followed by a multiple-choice test which must be passed. The test consists of 15 questions generated randomly from a pool of 40 questions and takes approximately 15-20 minutes. 80% of the questions need to be answered correctly to pass. After each failed test, the attendees receive a new set of 15 random questions. After three test runs, the participant must start from the beginning. The individual modules can only be processed in the order of module 1-5. The attendees can download and print the training certificate themselves after finishing all courses and assessments.

All training modules within a training course must be completed within two months. If the two-month period has expired and the four questionnaires have not been answered correctly, the online training must be restarted.

There are no reviews yet.

Only logged in customers who have purchased this product may leave a review.

Related products

Ivdr-update-training.

excl. 19% VAT

Free Next Day Delivery

7 days/week

14 years of experience

over 400000 customers

100% secure checkout

Genuine local stock

verified sources

Session expired

Please log in again. The login page will open in a new tab. After logging in you can close it and return to this page.

• Medical Science Liaison Manager
• Clinical Research Associate
• Pharmareferent
• Studienassistenz in Prüfstellen / Study Nurse
• Clinical Trial Assistant
• GCP Klinische Prüfung Arzneimittel und Medizinprodukte
• Prüfplantraining
• Clinical Project Management
• Risk Management
• Kommunikation Prüfzentrum
• BWL für Naturwissenschaftler*innen
• Medical English
• Stellenangebote
• Kooperationspartner
• Infomaterial
• Anmeldung und Finanzierung
• Infoveranstaltungen
• Messen und Veranstaltungen
• Wissenswertes

Clinical Research Associates koordinieren und überwachen den gesetzeskonformen Ablauf von klinischen Studien. Sie besuchen regelmäßig die Prüfzentren vor Ort und sind für die lückenlose Dokumentation zuständig.

Clinical Research Associates sind das kommunikative Bindeglied zwischen einem Auftragsforschungsinstitut und den an der Studie beteiligten Prüfzentren. Sie überwachen die Einhaltung der Gesetze und Regularien, die die Patientensicherheit im Rahmen von klinischen Studien gewährleisten. Die Aufgabengebiete sind vielseitig und variieren je nach Studienverlauf. Ein Clinical Research Associate wählt die Prüfzentren aus, schult die Studienteams und kontrolliert die Umsetzung der Studie gemäß Prüfplan und GCP Grundsätzen.

Der Clinical Research Associate ist in der Regel bei einem Pharmaunternehmen oder einer CRO angestellt, aber auch eine Tätigkeit als Freelancer ist möglich. Mit entsprechender Berufserfahrung eröffnen sich Perspektiven als Senior-CRA oder Projektmanager. Neben medizinischem Wissen und Kenntnissen zu den gesetzlichen Regularien sollten CRAs gut Englisch sprechen, kommunikationsstark sein und über ein hohes Maß an Reisebereitschaft verfügen.

Unsere Weiterbildung zum Clinical Research Associate eignet sich für folgenden Personenkreis:

• Naturwissenschaftler*innen mit oder ohne Promotion
• Quereinsteiger*innen mit medizinischem Interesse
• Pharmareferent*innen mit Berufserfahrung
• Angehörige technischer Assistenzberufe wie z.B. MTA oder PTA 
• Krankenschwestern oder Krankenpfleger mit Berufserfahrung
• Study Nurses

Gern beraten wir Sie zu Ihren individuellen Voraussetzungen in einem persönlichen Vorabgespräch.

Vollzeitkurs:

• 4 Monate Präsenzunterricht an einem unserer Standorte oder per Videokonferenz
• Seminarzeit werktäglich von 8:30 bis 16:00 Uhr
• Abschluss mit einer schriftlichen MC-Prüfung (open book) und einer mündlichen Prüfung
• ggf. förderbar durch die Agentur für Arbeit  

Blended Learning Kurs:

• kann in 6 oder 12 Monaten absolviert werden (1 oder 2 Seminarwochenenden pro Monat)
• modularisierter Kurs, laufender Einstieg möglich
• beinhaltet 26 Videokonferenzen und 6 E-Learning Module
• Abschluss mit einer schriftlichen MC-Prüfung (open book)

Die Weiterbildung zum Clinical Research Associate deckt verschiedene Themengebiete im Bereich der klinischen Forschung ab und eröffnet Ihnen dadurch vielseitige Jobperspektiven. Sie lernen die für eine Studie relevanten Dokumente und Unterlagen kennen und wir machen Sie mit den wichtigsten Gesetzen und Regularien vertraut. Der Vollzeitkurs beinhaltet zudem einen Überblick über die medizinischen Grundlagen, Medical English und ein Kommunikationstraining.  

Die Weiterbildung umfasst im Einzelnen folgende Inhalte:

• medizinische Grundlagen in Anatomie, Physiologie und Pathologie*
• pharmakologische Grundlagen*
• regulatorischen Grundlagen (ICH GCP, Arzneimittelgesetz, CTR ( EU-V 536/2014), Deklaration von Helsinki u.a.)
• Grundlagen klinischer Studien
• Zulassung von Human- und Tierarzneimitteln
• Zulassung von Medizinprodukten
• Gesundheitsökonomie
• Datenmanagement
• Behördeneinreichungen (EK, BOB, lokale Behörden)
• Qualitätssicherung und Kontrolle (SOPs, Audits, Inspektionen)
• Pharmakovigilanz
• Generierung und Handhabung von Studiendokumenten (Prüfplan, Essential Documents, ICF, CRF u.a.)
• Archivierung von Studienunterlagen
• Site Visits (PSV, SIV, MV, COV)
• Projektmanagement
• Medical English*
• Kommunikationstraining*

Mit * gekennzeichnete Inhalte werden nur im Rahmen des Vollzeitkurses vermittelt.  

Am Ende der Weiterbildung erhalten Sie folgende Zertifikate:

• Teilnahmebestätigung
• ICH GCP Zertifikat
• Zertifikat "Clinical Research Associate"

Der CRA Vollzeitkurs ist unter gegebenen Vorrausetzungen förderfähig mit einem Bildungsgutschein durch die Agentur für Arbeit.

Lassen Sie sich gern dazu von uns beraten!

Die Weiterbildung und die Jobperspektiven als Clinical Research Associate stellen wir regelmäßig im Rahmen unserer Info-Webinare vor. Nächste Termine: 24.04.2024, 11-12 Uhr 14.05.2024, 19-20 Uhr 17.06.2024, 18-19 Uhr

Wenn Sie unverbindlich an einem unserer Webinare teilnehmen möchten, melden Sie sich bitte hier an .  Möchten Sie uns lieber persönlich kennenlernen? Wir beraten  Sie gern telefonisch unter 0341 99 38 14 0 oder per E-Mail .

Broschüre Clinical Research Associate

Arzneimittelgesetz

EU-Medizinprodukte-Verordnung (MDR)

EU-In-Vitro-Diagnostik- Verordnung (IDRV)

CTR ( EU-V 536/2014)

Deklaration von Helsinki in Deutsch

Infomaterial anfordern Jetzt zum kostenlosen Webinar anmelden

Vollzeitkurs 03.06.2024 per Videokonferenz

Blended Learning Kurs

per Videokonferenz Einstieg monatlich möglich

Haben Sie Anregungen, Wünsche oder Kritik?

Pharmaakademie GmbH & Co. KG

Gerberstraße 15 04105 Leipzig

Telefon: +49 (0) 341 993814 0 Fax: +49 (0) 341 993814 19

Pharmaakademie

• Study Nurse
• Datenschutz

CLINICAL RESEARCH ASSOCIATE

Clinical research associate.

The European Center for Cardiovascular Research (CERC) is a CRO specialized in the design and management of international clinical trials dedicated to cardiovascular diseases.

Chaired by four interventional cardiologists, actors of clinical research for over 20 years, the CERC conducted clinical studies directly in line with the issues of cardiologists practicing in private or public hospitals.

CERC is currently supporting thirty studies for industrial promotions but also manages more than 10 “investigators initiated trials” whose purpose is the treatment of conditions / comorbidities for which there is no satisfactory therapeutic strategy.

CERC is an Entreprise à Mission.

CERC is currently looking for Clinical Research Associates to be involved in international clinical studies.

Job description

– Responsible for site management from initiation to close-out in accordance with study specific procedures, applicable SOPs, and ICH GCP guidelines

– Remote monitoring via e-CRF

– Training and information for investigators and the clinical study

– Privileged contact with investigators centers

– On site monitoring of patient safety (review of SAEs, AEs)

– Generate visit reports in compliance with the monitoring plan

– Update all relevant tracking systems on an ongoing basis

– May assist the Clinical Project Leader in regulatory submissions.

Qualifications

– Excellent interpersonal, verbal and written communication skills – Ability to prioritize multiple tasks and achieve project timelines – Ability to take initiative and work autonomously

– Computer skills (Microsoft Office)  

– A Master or higher graduate degree within a science related field, with a CRA training

– Significant experience in performing a Clinical Research Associate role at least 1 year minimum.

Language Skills

Competent in written and oral English, French, and (mandatory) German or Spanish.

Permanent employment contract.

Position to be filled immediately.

Working conditions

12 reasons for joining us👉 https://www.cerc-europe.org/12-reasons/

INTERESTED ?

COVER LETTER

• home         contact         deutsch    

Clinical Research Associate (CRA) Germany

Munich, Bavaria-based Senior CRA offering his services

Medical Doctor degree

Clinical Research Associate since 2007

Experience as a physician in anesthesiology, internal medicine and radiation oncology, as a monitor also in ophthalmology, cardiology, pain management, rheumatology and medical devices.

Munich-Based Freelance CRA

Contracting a local CRA-freelancer in (South) Germany means lower travel times and costs, knowledge of local regulatory issues and better cultural awareness.

For more information, please contact me via the contact form .  

ENGLISH JOBS GERMANY

7865 clinical research english-speaking jobs in germany, note : some links might not work outside the european union, devops engineer | center for humans and machines.

• Max Planck Institute for Human Development

Center for Humans and Machines in this tech role 🤖 Serve as a cross-functional leader who translates research ..needs into technical require-mentsLead the technical development of small- and large-scale online research ..The research questions they examine include how people make effective decisions even under time pressure..monitor progress (including cost estimation and moni-toring)Act as project owner in large-scale online research ..blueprintsProvide technical support in the use and adaptation of experimental blueprintsOnboard and manage Research

VP Clinical Development

• The University of Texas MD Anderson Cancer Center

individual clinical trials Collaborate with company Global Clinical Research teams to drive scientific..Lead the development of strategic scientific and medical input into clinical research programs and.., lead medical oversight of clinical research programs, including medical monitoring, safety evaluations..Health sciences related degree preferred Proven experience (15+ years) in industry clinical research .. Research and Operations, Quality, Regulatory Affairs, Pharmacovigilance, Research and Development, Global

Scientist, Clinical Research

• PSG Global Solutions

Conduct hands on scientific research to understand the fundamentals of the methods, materials and the..scientific leadership and hands on technical expertise in trouble shooting and conducting analytical research

Clinical Research Associate

• Katalyst Healthcares & Life Sciences

Research field...Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research ..including coordination and oversight of all CRO/ clinical site/vendor activities, liaison between Clinical ..in Clinical trials of drugs, biologics and medical devices...We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical

Working Student - IT Operations (m/f/d)

• holoride GmbH
• 80799, München

Research & Development You will ​assist in the administration and procurement of company ​hardware and

PhD Candidates (f/m/x) – Functional Omics of Neurodegenerative Diseases

• Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE)

, clinical research , health care research , population health science, and systems medicine (dzne.de)...Available clinical data include detailed structural and functional brain imaging, cognitive and neurological..or large-scale clinical studies First programming experience (preferably in R) Excellent analytical..öffentlichen Dienst) The PhD position will be integrated into the Bonn International Graduate School of Clinical ..The German Center for Neurodegenerative Diseases (DZNE) is a world-leading internationally oriented research

Financial Advisor

• Eduard Tonoyan
• Baden-Württemberg
• remote work

Research and analyze financial products to meet client requirements and objectives.

Clinical Research Associate (all levels), FSP, home based, client dedicated

• Syneos Health, Inc.

Clinical Research Associate (all levels), FSP, home based, client dedicatedUpdated: March 12, 2024Location..: Germany-Europe - DEU-Home-Based, GermanyJob ID:24002032Senior Clinical Research Associate ISyneos Health..We translate unique clinical , medical affairs and commercial insights into outcomes to address modern..market realities.Our Clinical Development model brings the customer and the patient to the center of..We translate unique clinical , medical affairs and commercial insights into outcomes to address modern

Senior Project Data Manager

• INC Research

INC Research is a full-service clinical research organization, providing the full range of Phase I to.. research industry...Contract Research Organization (CRO) experience preferred...Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices...Direct exposure to Oracle Clinical , Rave, or Inform systems.

Clinical Research Specialist

• Real Staffing

attention to detail and accuracy.QualificationsPrevious clinical research experienceAbility to prioritize..assist with oversight of activities performed by Contract Research Organizations (e.g... research experience.Must have strong written, oral, and interpersonal communication skills and high..more about Real Staffing Group please visit http://www.RealStaffingGroup.com Job DescriptionClinical Research ..Interface with, and assure training of investigators, site staff, and Medtronic clinical staff.

Clinical research experience required...Job DescriptionJob Title: Clinical Research Specialist Location: Manhattan, NYC Duration: 6 months (..the Principal Investigator (PI) in recruiting patients for clinical studies..· The position arranges and oversees all clinical trial activities and plays a key role in assisting..guidance on the administration of the compliance, financial, personnel and other related aspects of clinical

Clinical Research Scientist

• LanceSoft Inc

research in the pharmaceutical industry• A thorough understanding of clinical research methodology including..Doctoral (PharmD or PhD) degree preferred Minimum of 5-7 years of experience in clinical research in.. research techniques in the oncology therapeutic area;• Bachelor’s Required..., Investigator Brochure, etc)• Performs literature search and data analysis to address research questions..studies• Prepare and review project and study documents including clinical trial protocols, clinical

• Mitsubishi Tanabe Pharma America

The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient..Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provideleadership..in the direction, planning, execution, and interpretation of clinical protocols, research , data collection..Monitors adherence to protocols and determines study completion.The Clinical Research Scientist may interact..Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research -driven pharmaceutical

• Artech Information System LLC

Clinical Operations Manager and CRO, manage scopes of work/budgets/invoice payments...trials including coordination and oversight of all CRO/ clinical site/vendor activities, liaison between..DescriptionMedical Affairs - Global OncologyAssist in the management of the day to day operations of clinical

Senior Manager Global Oncology PRO (m/f/x)

• Daiichi Sankyo Europe GmbH

The person will work with other teams and the Health Economics Outcomes Research (HEOR) asset leads to.. research question and objectives Ensure consistency between planned and final PRO output Ensure PROs..FDA) Provide support with execution of other initiatives and research deliverables across the broader..support the clinical development and value creation of the company's oncology assets, by ensuring..This person will align with the HEOR asset lead as well as with clinical , statistical and other relevant

Scientific Code Developer (m/f/div) for HPC

• Max Planck Computing & Data Facility
• Garching bei München

The Max Planck Computing and Data Facility (MPCDF), based at the research campus Garching near Munich..financed by the employer Reduced rates for certain insurance policies Family service at the Garching research

Clinical Services: Image Analysis Research Specialist

• Canfield Scientific

Clinical Services: Image Analysis Research SpecialistThe ideal candidate for our Image Analysis Research ..Specialist position is an individual with interest in 2D and 3D clinical research and image analysis..trial research programsFollows research driven workflows to produce objective image analysis dataProvide..Canfield has supported over 3,200 clinical studies, works worldwide with thousands of clinical study..high quality clinical image processing and quality checksReview and analyze objective measure data for

Electrical Engineer

• Flexoptix GmbH
• 64297, Darmstadt

About FLEXOPTIX Since 2008, Flexoptix has been successfully developing and marketing solutions for network transceivers under the motto "Less bullshit more engineering". We are in the telecommunications sector and, with more than 75 employees, we have positioned ourselves in an internationally growing market thanks to our “orange” and pragmatic mindset.

Clinical Director, Clinical Research – Oncology European Clinical Development

• Merck Sharp & Dohme (MSD)

of research findings at international scientific meetings and providing European clinical insights from..Job DescriptionWe are a research -driven biopharmaceutical company...We believe that a research -driven enterprise dedicated to world-class science can succeed by inventing..You will also be able to supplement your research activities by taking advantage of the technologies..development strategies and executing on short- and long-term research objectives.Support in creating

Clinical Operations Lead

• Alimentiv Inc.

Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator..Demonstrated ability in report writing and strong ability to critically understand clinical research ..operations and the clinical project team...The COL acts as a primary liaison between the CRAs and the clinical project team...Responsible for the clinical operations of a project within a defined regional/global level.

Email me future jobs like these

Clinical research in ....

• Ingenieurwesen
• Wasserstofftechnologie und -wirtschaft (M.Sc.)
• CAS - Certificate of Advances Studies
• DAS - Diploma of Advances Studies
• Kurskalender
• Dresdner Medizinrechtssymposium
• Ethikberater:in im Gesundheitswesen (Zertifikat K1 nach AEM)
• Koordinator:in für Ethikberatung im Gesundheitswesen (Zertifikat K2 nach AEM)
• Supervisionskurs für die Ethikberatung
• Trainer:in für Ethikberatung im Gesundheitswesen (Theorie Zertifikat K3 nach AEM)
• Case Management
• Krankenhausreform im Fokus – Herausforderungen und Chancen | Kursreihe
• MHFA Ersthelfer - Kurse für psychische Gesundheit
• Planungskompetenzen auf Station
• Stations- und Funktionsleitung
• Corporate Community Management
• Digitale Technologien: Erfolgsfaktoren, Potenziale & Innovationen
• Innovatives Risikomanagement: KI-gestützte Methoden und Risikoanalyse
• Employee Experience
• Mediation (DAS)
• Rhetorik, Gesprächsführung und Kreatives Schreiben

Men and Women on Fire l Hormone im Alter

Cannabis in der medizin.

• Qualifizierung zum medizinischen Sachverständigen (CPU)
• Wissenstransfer im Eisenbahnbetriebslabor
• Wasserstofftechnologie und -wirtschaft (CAS): Mobilität, Industrie und Gebäudetechnik
• DIU Schreibakademie
• Study in Dresden
• Living in Dresden
• Logistics Management MBA International
• Clinical Research
• Non-Destructive Testing
• Industrial Management in Microelectronics
• Veranstaltungen
• Whats App Studienberatung
• Zulassungsvoraussetzungen
• Finanzierung und Stipendien
• Unsere Experten
• 20 Jahre DIU Historie
• DIU News Überblick
• Netzwerk- und Praxispartner

Design and conduct a high level clinical trial

Get more detailed information!

Unsere Fachbereiche

• Bildung, Kommunikation & Kultur
• Gesundheitswesen
• Wirtschaft, Recht & Management

Clinical Research (M.Sc.)

Out-of-the-box-thinking and multidisciplinary collaboration.

The Master's Program in Clinical Research (MPCR) at Dresden International University is designed to provide students with a comprehensive understanding of the methodology and practice of clinical research. Our program creates an international platform for medical scientists that emphasizes teamwork, creativity, out-of-the-box thinking, and multidisciplinary collaboration. With our strong partnership with Harvard University, we recognize the grades of the international nine-month distance-learning program "Principles and Practice of Clinical Research (PPCR)" * offered by the Harvard TH Chan School of Public Health , allowing graduates of the PPCR course to directly continue with our Master's program and shorten their study time.

Our program provides students with the opportunity to gain a deeper understanding of clinical research and prepares them for a successful career in the field. Upon completion of the program, students will receive the academic title of Master of Science (M. Sc.) from the Dresden International University. Our program is designed to equip students with the knowledge and skills they need to advance in their careers and make a positive impact in the field of clinical research.

At Dresden International University, our approach to teaching is centered on collaboration and active learning. Our lecturers work closely with students to generate new ideas and research questions, while also helping to develop individual skills and thinking strategies. This close, open relationship between students and teachers not only fosters a deeper understanding of the subject matter but also creates a valuable professional network for our students.

Our curriculum is built on a solid theoretical foundation but also places a strong emphasis on the practical application of clinical research. Our students are trained to negotiate contracts, independently develop and implement clinical research projects, and evaluate the potential risks and benefits of their projects. This approach ensures that our students are well-prepared to succeed in the field of clinical research after graduation.

*About the PPCR program:

• For a detailed program of the PPCR course, please visit www.hsph.me/ppcr
• PPCR program application form

Target group

• "Principles and Practice of Clinical Research (PPCR)" program graduates and students
• Medics and nurses interested in clinical research
• Researcher in the medical field

Overview of the study contents

Module 1 - basics of clinical research - theory*.

Introduction to Clinical Trials, Theory of Study Conduction Methods, Principles of Statistical Analysis, Designing a Clinical Trial, Principles of Trial Management and Study Types.

• how to formulate a research question (FINER, PICOT)
• select study population (inclusion/exclusion criteria)
• randomization
• blinding methods and unblinding problems
• statistical methods (data distribution and classification, statistical tests, sample size calculation, survival analysis, missing data imputation and meta-analysis)
• data collection (electronic capture)
• data monitoring (interim analysis, DSMB)
• scientific reporting (include training in manuscript writing)
• types of study designs and clinical study phases (observational studies, non-inferior and adaptive designs and randomized clinical trials, phase 0 - IV)

*The module 1 includes the content of the PPCR program - a recognition of the program is possible

Module 2 - Advanced Clinical Research - Applications

Applied Biostatistics, Data Visualization,  Hands-on-Workshop on R / RStudio

• applied biostatistics and clinical practice
• data visualization, data and data sources
• R/RStudio hands-on-workshop

Module 3 - Innovations of Clinical Research

Scientific Presentation, Handling of Modern Media, Health Economic Outcome Research, Big Data and AI, Real World Data / Real World Evidence, Health Technology Assessment

• scientific presentation
• handling of modern media
• health economic outcome research
• big data and artificial intelligence (ai)
• real world data (rwd) / real world evidence (rwe)
• health technology assessment (hta)

Master´s Thesis

After finishing these modules students will complete their Master's Thesis on a topic in the field of Clinical Research supervised by lecturers of the Master's Program.

Publications - excerpt

In our master’s program the majority of theses are publications in international peer-reviewed journals..

List of selected publications:

• Serrano-Castro ML, Garro-Zúñiga M, Simon E, Tamayo A, Siepmann T. Clinical and Imaging Phenotypes and Outcomes in a Costa Rican Cohort of Acute Ischemic Stroke Survivors: A Retrospective Study. J Clin Med. 2023 Jan 30;12(3):1080. doi: 10.3390/jcm12031080. PMID: 36769728; PMCID: PMC9917829.
• Eckardt JN, Stasik S, Röllig C, Sauer T, Scholl S, Hochhaus A, Crysandt M, Brümmendorf TH, Naumann R, Steffen B, Kunzmann V, Einsele H, Schaich M, Burchert A, Neubauer A, Schäfer-Eckart K, Schliemann C, Krause SW, Herbst R, Hänel M, Hanoun M, Kaiser U, Kaufmann M, Rácil Z, Mayer J, Cerqueira T, Kroschinsky F, Berdel WE, Serve H, Müller-Tidow C, Platzbecker U, Baldus CD, Schetelig J, Siepmann T, Bornhäuser M, Middeke JM, Thiede C. Alterations of cohesin complex genes in acute myeloid leukemia: differential co-mutations, clinical presentation and impact on outcome. Blood Cancer J. 2023 Jan 24;13(1):18. doi: 10.1038/s41408-023-00790-1. PMID: 36693840; PMCID: PMC9873811.
• Conde Monroy D, Ibañez-Pinilla M, Sabogal JC, Rey Chaves C, Isaza-Restrepo A, Girón F, Vanegas M, Ibañez-Villalba R, Mirow L, Siepmann T. Survival Outcomes of Hepatectomy in Gastric Cancer Liver Metastasis: A Systematic Review and Meta-Analysis. J Clin Med. 2023 Jan 16;12(2):704. doi: 10.3390/jcm12020704. PMID: 36675632; PMCID: PMC9861719.
• Hackner D, Hobbs M, Merkel S, Siepmann T, Krautz C, Weber GF, Grützmann R, Brunner M. Impact of Patient Age on Postoperative Short-Term and Long-Term Outcome after Pancreatic Resection of Pancreatic Ductal Adenocarcinoma. Cancers (Basel). 2022 Aug 15;14(16):3929. doi: 10.3390/cancers14163929. PMID: 36010922; PMCID: PMC9406071.
• Lincango Naranjo EP, Garces-Delgado E, Siepmann T, Mirow L, Solis-Pazmino P, Alexander-Leon H, Restrepo-Rodas G, Mancero-Montalvo R, Ponce CJ, Cadena-Semanate R, Vargas-Cordova R, Herrera-Cevallos G, Vallejo S, Liu-Sanchez C, Prokop LJ, Ziogas IA, Vailas MG, Guerron AD, Visser BC, Ponce OJ, Barbas AS, Moris D. Robotic Living Donor Right Hepatectomy: A Systematic Review and Meta-Analysis. J Clin Med. 2022 May 5;11(9):2603. doi: 10.3390/jcm11092603. PMID: 35566727; PMCID: PMC9103024.
• Freitas V, Li X, Amitai Y, Au F, Kulkarni S, Ghai S, Mulligan AM, Bromley M, Siepmann T. Contralateral Breast Screening with Preoperative MRI: Long-Term Outcomes for Newly Diagnosed Breast Cancer. Radiology. 2022 Aug;304(2):297-307. doi: 10.1148/radiol.212361. Epub 2022 Apr 26. PMID: 35471109.
• Aabdien M, Abdallah I, Bougmiza MI, Siepmann T, Illigens B. Perceptions and attitudes toward participation in clinical research in the Eastern Mediterranean Region: A systematic review. Medicine (Baltimore). 2022 Aug 19;101(33):e29959. doi: 10.1097/MD.0000000000029959. PMID: 35984206; PMCID: PMC9388020.
• Grigorescu M, Kemmner S, Schönermarck U, Sajin I, Guenther W, Cerqueira TL, Illigens B, Siepmann T, Meiser B, Guba M, Fischereder M, Stang MJ. Disqualification of Donor and Recipient Candidates From the Living Kidney Donation Program: Experience of a Single-Center in Germany. Front Med (Lausanne). 2022 Jun 10;9:904795. doi: 10.3389/fmed.2022.904795. PMID: 35755074; PMCID: PMC9226311.
• Lincango Naranjo EP, Garces-Delgado E, Siepmann T, Mirow L, Solis-Pazmino P, Alexander-Leon H, Restrepo-Rodas G, Mancero-Montalvo R, Ponce CJ, Cadena-Semanate R, Vargas-Cordova R, Herrera-Cevallos G, Vallejo S, Liu-Sanchez C,
• Prokop LJ, Ziogas IA, Vailas MG, Guerron AD, Visser BC, Ponce OJ, Barbas AS, Moris D. Robotic Living Donor Right Hepatectomy: A Systematic Review and Meta-Analysis. J Clin Med. 2022 May 5;11(9):2603. doi: 10.3390/jcm11092603. PMID: 35566727; PMCID: PMC9103024.
• Yousaf Z, Ata F, Chaudhary H, Krause F, Illigens BM, Siepmann T. Etiology, pathological characteristics, and clinical management of black pleural effusion: A systematic review. Medicine (Baltimore). 2022 Feb 25;101(8):e28130. doi:10.1097/MD.0000000000028130. PMID: 35212269; PMCID: PMC8878788.
• Schmidt MW, Battista MJ, Schmidt M, Garcia M, Siepmann T, Hasenburg A, Anic K. Efficacy and Safety of Immunotherapy for Cervical Cancer-A Systematic Review of Clinical Trials. Cancers (Basel). 2022 Jan 17;14(2):441. doi: 10.3390/cancers14020441. PMID: 35053603; PMCID: PMC8773848.
• Eltemamy MA, Tamayo A, Altarsha E, Sedghi A, Pallesen LP, Barlinn J, Puetz V, Illigens BM, Barlinn K, Siepmann T. erebrovascular Risk Profiles in a Saudi Arabian Cohort of Young Stroke Patients. Front Neurol. 2021 Nov 12;12:736818.
• doi: 10.3389/fneur.2021.736818. PMID: 34867720; PMCID: PMC8632802.
• Tamayo A, Siepmann T. Regulation of Blood Flow in the Cerebral Posterior Circulation by Parasympathetic Nerve Fibers: Physiological Background and Possible Clinical Implications in Patients With Vertebrobasilar Stroke. Front Neurol. 2021 Oct 29;12:660373. doi: 10.3389/fneur.2021.660373. PMID: 34777191; PMCID: PMC8585859.
• Marin-Concha J, Rengifo P, Tapia P, Kaiser D, Siepmann T. Prevalence and characteristics of the aberrant anterior tibial artery: a single-center magnetic resonance imaging study and scoping review. BMC Musculoskelet Disord. 2021 Nov
• 2;22(1):922. doi: 10.1186/s12891-021-04801-9. PMID: 34727902; PMCID: PMC8564972.
• Vorisek CN, Zurakowski D, Tamayo A, Axt-Fliedner R, Siepmann T, Friehs I. Postnatal circulation in patients with aortic stenosis undergoing fetal aortic valvuloplasty: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2022 May;59(5):576-584. doi: 10.1002/uog.24807. Epub 2022 Apr 11. PMID: 34726817.
• Mohamed MFH, Danjuma M, Mohammed M, Mohamed S, Siepmann M, Barlinn K, Suwileh S, Abdalla L, Al-Mohanadi D, Silva Godínez JC, Elzouki AN, Siepmann T. Myxedema Psychosis: Systematic Review and Pooled Analysis. Neuropsychiatr Dis Treat. 2021 Aug 18;17:2713-2728. doi: 10.2147/NDT.S318651. PMID: 34447249; PMCID: PMC8382967.
• Farina A, Moro F, Fasslrinner F, Sedghi A, Bromley M, Siepmann T. Strength of clinical evidence leading to approval of novel cancer medicines in Europe: A systematic review and data synthesis. Pharmacol Res Perspect. 2021 Aug;9(4):e00816. doi: 10.1002/prp2.816. PMID: 34232554; PMCID: PMC8262606.
• Hajelssedig OE, Zorron Cheng Tao Pu L, Thompson JY, Lord A, El Sayed I, Meyer C, Shaukat Ali F, Abdulazeem HM, Kheir AO, Siepmann T, Singh R. Diagnostic accuracy of narrow-band imaging endoscopy with targeted biopsies compared with standard endoscopy with random biopsies in patients with Barrett's esophagus: A systematic review and meta-analysis. J Gastroenterol Hepatol. 2021 Oct;36(10):2659-2671. doi: 10.1111/jgh.15577. Epub 2021 Jul 5. PMID: 34121232.
• Soldatelli MD, Siepmann T, Illigens BM, Souza Dos Santos V, Lucena da S Torres I, Fregni F, Caumo W. Mapping of predictors of the disengagement of the descending inhibitory pain modulation system in fibromyalgia: an exploratory study. Br J Pain. 2021 May;15(2):221-233. doi: 10.1177/2049463720920760. Epub 2020 May 30. PMID: 34055343; PMCID: PMC8138619.
• Struja T, Koch D, Haubitz S, Mueller B, Schuetz P, Siepmann T. Quality of life after hospitalization predicts one-year readmission risk in a large Swiss cohort of medical in-patients. Qual Life Res. 2021 Jul;30(7):1863-1871. doi: 10.1007/s11136-021-02867-5. Epub 2021 May 18. PMID: 34003435.
• Hassan WM, Bakry MS, Siepmann T, Illigens B. Association of RASSF1A, DCR2, and CASP8 Methylation with Survival in Neuroblastoma: A Pooled Analysis Using Reconstructed Individual Patient Data. Biomed Res Int. 2020 Dec 15;2020:7390473. doi: 10.1155/2020/7390473. PMID: 33381579; PMCID: PMC7755470.
• Inci MG, Richter R, Woopen H, Rasch J, Heise K, Anders L, Mueller K, Nasser S, Siepmann T, Sehouli J. Role of predictive markers for severe postoperative complications in gynecological cancer surgery: a prospective study (RISC-GynTrial). Int J Gynecol Cancer. 2020 Dec;30(12):1975-1982. doi: 10.1136/ijgc-2020-001879. Epub 2020 Nov 27. PMID: 33246921.
• Kutz A, Ebrahimi F, Aghlmandi S, Wagner U, Bromley M, Illigens B, Siepmann T, Schuetz P, Mueller B, Christ-Crain M. Risk of Adverse Clinical Outcomes in Hyponatremic Adult Patients Hospitalized for Acute Medical Conditions: A Population-Based Cohort Study. J Clin Endocrinol Metab. 2020 Nov 1;105(11):3428–36. doi: 10.1210/clinem/dgaa547. PMID: 32818232; PMCID: PMC7500475.
• Lopes DG, Tamayo A, Schipp B, Siepmann T. Cost-effectiveness of edoxaban vs low-molecular-weight heparin and warfarin for cancer-associated thrombosis in Brazil. Thromb Res. 2020 Dec;196:4-10. doi: 10.1016/j.thromres.2020.08.014. Epub 2020 Aug 11. PMID: 32810773.
• Ebrahimi F, Kutz A, Wagner U, Illigens B, Siepmann T, Schuetz P, Christ-Crain M, Mueller B, Christ ER. Excess Mortality Among Hospitalized Patients With Hypopituitarism-A Population-Based, Matched-Cohort Study. J Clin Endocrinol Metab. 2020 Nov 1;105(11):dgaa517. doi: 10.1210/clinem/dgaa517. PMID: 32785679.
• Scheel-Sailer A, Sailer CO, Lampart P, Baumberger M, Berger M, Mueller G, Sigrist-Nix D, Schmitt K, Siepmann T, Pannek J. Examinations and assessments in patients with a newly acquired spinal cord injury - retrospective chart analysis as part of a quality improvement project. Swiss Med Wkly. 2020 Jul 30;150:w20291. doi: 10.4414/smw.2020.20291. PMID: 32730632.
• Mohamed MFH, Siepmann T, Suwileh S, Mohammed MH, Mohamed S, Abdalla LO, Elzouki AN, Mahmoud MH, Al-Mohanadi D, Danjuma M. Myxedema psychosis: A protocol for a systematic review and a pooled analysis. Medicine (Baltimore). 2020 Jun 26;99(26):e20778. doi: 10.1097/MD.0000000000020778. PMID: 32590756; PMCID: PMC7328932.
• Cosgarea I, Griewank KG, Ungureanu L, Tamayo A, Siepmann T. Deep Penetrating Nevus and Borderline-Deep Penetrating Nevus: A Literature Review. Front Oncol. 2020 May 20;10:837. doi: 10.3389/fonc.2020.00837. PMID: 32509588; PMCID:PMC7251176.
• Ruiz Segura LT, Figueroa Pérez E, Nowak-Wegrzyn A, Siepmann T, Larenas-Linnemann D. Food allergen sensitization patterns in a large allergic population in Mexico. Allergol Immunopathol (Madr). 2020 Nov-Dec;48(6):553-559. doi: 10.1016/j.aller.2020.02.004. Epub 2020 May 20. PMID: 32444115.
• Klein J, Siepmann T, Schackert G, Ziemssen T, Juratli TA. Peripheral nerve field stimulation in medically refractory trigeminal neuralgia attributed to multiple sclerosis. J Neurosurg. 2020 Mar 20;134(3):1244-1250. doi: 10.3171/2019.12.JNS192261. PMID: 32197243.
• daSilva-deAbreu A, Zhao Y, Serauto-Canache A, Alhafez B, Aribindi K, Balan P, Loyalka P, Kaaaar B, Smalling R, Anderson HV, Dhoble A, Siepmann T, Arain SA. Predictors and Prognostic Impact of In-hospital Bleeding after TranscatheterAortic Valve Replacement According to BARC and VARC-2 Definitions. Braz J Cardiovasc Surg. 2019 Dec 1;34(6):788-790. doi: 10.21470/1678-9741-2019-0275. PMID: 31793259; PMCID: PMC6894019.
• Negrão de Figueiredo G, Mueller-Peltzer K, Schwarze V, Marschner C, Zhang L, Rübenthaler J, Siepmann T, Illigens BW, Clevert DA. Long-term study analysis of contrast-enhanced ultrasound in the diagnosis of focal nodular hyperplasia. Clin Hemorheol Microcirc. 2020;74(4):441-452. doi: 10.3233/CH-190710. PMID: 31743989.
• Salguero MV, Al-Obaide MAI, Singh R, Siepmann T, Vasylyeva TL. Dysbiosis of Gram-negative gut microbiota and the associated serum lipopolysaccharide exacerbates inflammation in type 2 diabetic patients with chronic kidneydisease. Exp Ther Med. 2019 Nov;18(5):3461-3469. doi: 10.3892/etm.2019.7943. Epub 2019 Aug 26. PMID: 31602221; PMCID: PMC6777309.
• Yousif D, Bellos I, Penzlin AI, Hijazi MM, Illigens BM, Pinter A, Siepmann T. Autonomic Dysfunction in Preeclampsia: A Systematic Review. Front Neurol. 2019 Aug 6;10:816. doi: 10.3389/fneur.2019.00816. PMID: 31447757; PMCID: PMC6691156.
• Fleischmann DF, Unterrainer M, Corradini S, Rottler M, Förster S, la Fougère C, Siepmann T, Schwaiger M, Bartenstein P, Belka C, Albert NL, Niyazi M. Report of first recurrent glioma patients examined with PET-MRI prior to re-irradiation. PLoS One. 2019 Jul 24;14(7):e0216111. doi: 10.1371/journal.pone.0216111. PMID: 31339892; PMCID: PMC6655559.
• Pinter A, Szatmari S Jr, Horvath T, Penzlin AI, Barlinn K, Siepmann M, Siepmann T. Cardiac dysautonomia in depression - heart rate variability biofeedback as a potential add-on therapy. Neuropsychiatr Dis Treat. 2019 May 17;15:1287-1310. doi: 10.2147/NDT.S200360. PMID: 31190834; PMCID: PMC6529729.
• Mendoza-Velásquez JJ, Flores-Vázquez JF, Barrón-Velázquez E, Sosa-Ortiz AL, Illigens BW, Siepmann T. Autonomic Dysfunction in α-Synucleinopathies. Front Neurol. 2019 Apr 12;10:363. doi: 10.3389/fneur.2019.00363. PMID: 31031694; PMCID: PMC6474181.
• Uema D, Alves C, Mesquita M, Nuñez JE, Siepmann T, Angel M, Rego JFM, Weschenfelder R, Rocha Filho DR, Costa FP, Barros M, O'Connor JM, Illigens BM, Riechelmann RP. Carcinoid Heart Disease and Decreased Overall Survival among Patients with Neuroendocrine Tumors: A Retrospective Multicenter Latin American Cohort Study. J Clin Med. 2019 Mar 23;8(3):405. doi: 10.3390/jcm8030405. PMID: 30909590; PMCID: PMC6463128.
• Garcia M, Santos-Dias A, Bachi ALL, Oliveira-Junior MC, Andrade-Souza AS, Ferreira SC, Aquino-Junior JCJ, Almeida FM, Rigonato-Oliveira NC, Oliveira APL, Savio LEB, Coutinho-Silva R, Müller T, Idzko M, Siepmann T, Vieira RP. Creatine supplementation impairs airway inflammation in an experimental model of asthma involving P2 × 7 receptor. Eur J Immunol. 2019 Jun;49(6):928-939. doi: 10.1002/eji.201847657. Epub 2019 Apr 18. PMID: 30888047.
• Sofiyeva N, Siepmann T, Barlinn K, Seli E, Ata B. Gonadotropin-Releasing Hormone Analogs for Gonadal Protection During Gonadotoxic Chemotherapy: A Systematic Review and Meta-Analysis. Reprod Sci. 2019 Jul;26(7):939-953. doi: 10.1177/1933719118799203. Epub 2018 Oct 1. PMID: 30270741.
• Pacheco JT, Siepmann T, Barlinn J, Winzer S, Penzlin AI, Puetz V, von der Hagen M, Barlinn K. Safety and efficacy of recanalization therapy in pediatric stroke: A systematic review and meta-analysis. Eur J Paediatr Neurol. 2018 Nov;22(6):1035-1041. doi: 10.1016/j.ejpn.2018.07.013. Epub 2018 Aug 7. PMID: 30122515.
• Fasslrinner F, Schetelig J, Burchert A, Kramer M, Trenschel R, Hegenbart U, Stadler M, Schäfer-Eckart K, Bätzel M, Eich H, Stuschke M, Engenhart-Cabillic R, Krause M, Dreger P, Neubauer A, Ehninger G, Beelen D, Berdel WE, Siepmann T,Stelljes M, Bornhäuser M. Long-term efficacy of reduced-intensity versus myeloablative conditioning before allogeneic haemopoietic cell transplantation in patients with acute myeloid leukaemia in first complete remission:retrospective follow-up of an open-label, randomised phase 3 trial. Lancet Haematol. 2018 Apr;5(4):e161-e169. doi: 10.1016/S2352-3026(18)30022-X. Epub 2018 Mar 14. PMID: 29550384.
• Heppt MV, Siepmann T, Engel J, Schubert-Fritschle G, Eckel R, Mirlach L, Kirchner T, Jung A, Gesierich A, Ruzicka T, Flaig MJ, Berking C. Prognostic significance of BRAF and NRAS mutations in melanoma: a German study from routinecare. BMC Cancer. 2017 Aug 10;17(1):536. doi: 10.1186/s12885-017-3529-5. PMID: 28797232; PMCID: PMC5553744.
• Riediger C, Schuster T, Barlinn K, Maier S, Weitz J, Siepmann T. Adverse Effects of Antidepressants for Chronic Pain: A Systematic Review and Meta-analysis. Front Neurol. 2017 Jul 14;8:307. doi: 10.3389/fneur.2017.00307. PMID: 28769859; PMCID: PMC5510574.
• Schnabel A, Range U, Hahn G, Siepmann T, Berner R, Hedrich CM. Unexpectedly high incidences of chronic non-bacterial as compared to bacterial osteomyelitis in children. Rheumatol Int. 2016 Dec;36(12):1737-1745. doi: 10.1007/s00296-016-3572-6. Epub 2016 Oct 11. PMID: 27730289.
• Spieth PM, Kubasch AS, Penzlin AI, Illigens BM, Barlinn K, Siepmann T. Randomized controlled trials - a matter of design. Neuropsychiatr Dis Treat. 2016 Jun 10;12:1341-9. doi: 10.2147/NDT.S101938. PMID: 27354804; PMCID: PMC4910682.
• Nassir M, Guan J, Luketina H, Siepmann T, Rohr I, Richter R, Castillo-Tong DC, Zeillinger R, Vergote I, Van Nieuwenhuysen E, Concin N, Marth C, Hall C, Mahner S, Woelber L, Sehouli J, Braicu EI. The role of HE4 for prediction of recurrence in epithelial ovarian cancer patients-results from the OVCAD study. Tumour Biol. 2016 Mar;37(3):3009-16. doi: 10.1007/s13277-015-4031-9. Epub 2015 Sep 29. PMID: 26419591.
• Seidlitz A, Siepmann T, Löck S, Juratli T, Baumann M, Krause M. Impact of waiting time after surgery and overall time of postoperative radiochemotherapy on treatment outcome in glioblastoma multiforme. Radiat Oncol. 2015 Aug  16;10:172. doi: 10.1186/s13014-015-0478-5. PMID: 26276734; PMCID: PMC4554319.
• Woopen H, Richter R, Chekerov R, Siepmann T, Ismaeel F, Sehouli J. The influence of comorbidity and comedication on grade III/IV toxicity and prior discontinuation of chemotherapy in recurrent ovarian cancer patients: An individual participant data meta-analysis of the North-Eastern German Society of Gynecological Oncology (NOGGO). Gynecol Oncol. 2015 Sep;138(3):735-40. doi:10.1016/j.ygyno.2015.07.007. Epub 2015 Jul 13. PMID: 26185017.
• Lohkamp LN, Öllinger R, Chatzigeorgiou A, Illigens BM, Siepmann T. Intraoperative biomarkers in renal transplantation. Nephrology (Carlton). 2016 Mar;21(3):188-99. doi: 10.1111/nep.12556. PMID: 26132511.

Scientific Directors

Dr. Ben M. W. Illigens, MBI

Instructor in Neurology, Beth Israel Deaconess Medical Center Boston, MA United States and Director, German Sites Development Principles and Practice of Clinical Research Harvard T.H. Chan School of Public Health

Prof. Dr. med. habil. Timo Siepmann, FAHA

Attending Physician, Head of Cerebrovascular Outpatient Clinic (Department of Neurologie, University Hospital Carl Gustav Carus), Site Director, Principles and Practice of Clinical Research (Harvard TH Chan School of Public Health), Managing Director, Reformed Medical Degree Program (Technische Universität Dresden)

Lecturers and TA´s - excerpt

Teaching staff.

Our faculty and staff are internationally recognized for their teaching in clinical research.

Lecturers (excerpt)

• Prof. Dr. med. habil. Timo Siepmann,  Attending Physician, Head of Cerebrovascular Outpatient Clinic (Department of Neurologie, University Hospital Carl Gustav Carus), Site Director, Principles and Practice of Clinical Research (Harvard TH Chan School of Public Health), Managing Director, Reformed Medical Degree Program (Technische Universität Dresden)
• Dr. Ben Illigens , MBI
• Marc Eisele,  Director Centre for Media Technology in Medicine, Carl Gustav Carus University Hospital
• Dr. Oliver Fiala,  Senior Research Advisor, Save the Children UK
• PD Dr. Ingeborg Friehs , MD, Instructor in Surgery Department of Cardiac Surgery Children's Hospital Boston, Harvard Medical School, Boston United States
• Prof. Alexandra Pintér,  MD, Assistant professor of physiology Institute of Human Physiology and Clinical Experimental Research, Semmelweis University, Budapest Hungary
• Prof. Dr. Bernhard Schipp , Professor of Business and Economics Quantitative Methods, esp. Econometrics, Technische Universität Dresden, Dresden Germany

Teaching Assistants (TA´s)

• Miluska Bromley , MD, MSc, Senior TA, Plastic and Reconstructive Surgery Resident
• Mohamed Hashim Mahmoud , MD, ABHS-FM, Family Medicine, West Bay Training Center, Doha - Qatar
• Arturo Tamayo , MD, FAHA, Assistant Professor of Neurology University of Manitoba
• Tiago Lemos Cerqueira , MD, Nephrology Center of The Evangelical Hospital – Betim Unit
• Monique Garcia,  PharmD, MD Student - Pontifícia Universidade Católica de Minas Gerais (PUC-MG)
• Ahmed Fouad Abdelwahed Mohamed
• Cristina Dominguez,  Pediatric Urologist in Fundacion Santa Fe de Bogota in Colombia and a clinical professor at Universidad de los Andes
• Erlon Oliveira de Abreu Silva, MD,  Internist, Clinical and Interventional Cardiologist; Researcher HCor Research Institute

Admission requirements

• completed university studies (240 ECTS) which are recognised in your country of origin
• registration for the PPCR course of “Harvard T.H. Chan School of Public Health” or you have a certificate about passing this course
• proof of currently working in the field of clinical research
• and at least one-year of professional experience

Admission requirements for studying at the DIU

GET MORE DETAILED INFORMATION

Dieser Studiengang ist akkreditiert

Your contact

By our experts.

Dipl. Sportwiss. Petra Schmitz

+49 351 40470 - 138

[email protected]

flexible learning

interactive videoconference based live lectures and virtual plattforms for every time collaboration between students themselves and with lecturers

well-founded expert knowledge

lecturers with a high level of theoretical and practical knowledge offer interesting discussions on current and future topics

extensive exchange

international students with experiences of their own specific field enable interesting and exciting exchanges within the study group

Das könnte Sie auch interessieren

Health Care Management (MBA)

Fachbereich Medizin

Medizinrecht (LL.M.)

Multiple Sklerose Management (M.Sc.)

Parodontologie und Implantattherapie (M.Sc.)

Präventive und funktionelle Medizin (M.Sc.)

Qualifizierung zum Medizinischen Sachverständigen (cpu)

Some text in the modal.

Wir verwenden die Daten laut unseren Datenschutzbestimmungen.

Ich stimme den Datenschutzbestimmungen zu

Es gab Probleme. Bitte überprüfen Sie Ihre Angaben.

CCRA Certification

Ccra® (certified clinical research associate) is a credential formally recognizing clinical research professionals with experience monitoring and supervising the conduct and progress of clinical trials on behalf of a sponsor., this trusted mark of excellence in clinical research is awarded to clinical researchers who have demonstrated proficiency of specific knowledge and skills by passing the standardized ccra® certification exam..

Apply for Your Exam

Clinical research professional with 3,000 hours of verifiable work experience are eligible to sit for the CCRA ® Exam. Complete eligibility criteria is defined in the Academy’s  policy manual .

What qualifies as work experience, work related to human subject research, paid contractual agreement – employer/employee, can be verified by acrp through employer, what is excluded from work experience, any work that is part of a degree track or education program, any experience older than ten years, internships paid or unpaid.

Clinical research professionals with 1,500 hours of verifiable work experience and a clinical research degree are eligible to site for the CCRA ® Exam.

What qualifies as a clinical research degree, any degree awarded in clinical research from a chea accredited institution, major in clinical research, what does not qualify, any degree not in clinical research (biology, psychology, public health, epidemiology, nursing, doctorate), graduate certificate programs.

The CCRA ® exam consists of 125 multiple choice questions that must be answered within 180 minutes.

The exam is referenced only to the international conference on harmonization (ich) guidelines. no other regulatory framework is tested, including country-specific regulations (i.e, fda or ema)., the following are the only references for which the ccra ® certification exam content can be supported:, ccra ® exam detailed content outline >, guideline for good clinical practice e6 (r2) >, definitions and standards for expedited reporting (e2a) >, general considerations for clinical trials (e8) >, statistical principles for clinical trials (e9) >, clinical trials in pediatric population (e11) >, the declaration of helsinki (doh) >, the global ccra ®  exam committee uses psychometrically sound practices to develop certified clinical research associate (ccra) examinations that meet the current test specifications as determined by the most recent job task analysis (jta)..

Review the Detailed Content Outline and make sure your experience and work hours are appropriate, as outlined in the Eligibility tab.

We also strongly encourage you to review the entire acrp certification handbook , which provides full details about every facet of acrp certification..

Create a free ACRP account so you can begin the application process. Follow the on-screen prompts to enter any requested information and documentation.

If you already have an acrp account, please proceed to step three., create account >.

You’re almost there! Please note, applications selected for audit will undergo a formal review by ACRP’s subject matter experts. In most instances, you will receive a status update about your application within 7 business days.

In accordance with the americans with disabilities act, acrp will provide reasonable accommodations for candidates with disabilities. please complete this special accommodations form for submission with your application before proceeding., acrp’s testing partner psi offers in-person testing, as well as on-demand remote testing available 24 hours a day, every day, during the testing windows., watch these videos to learn what to expect from each option before scheduling your exam..

Find Test Centers Near You >

Schedule your in-person exam >.

Schedule Your Remote Exam >

Check system requirements >.

The best way to prepare for the CCRA ® exam is to fully understand the scope of the exam content and its references.

Please be sure to thoroughly review the following:, acrp certification handbook >, remember: the exam is referenced only to the international conference on harmonization guidelines. no other regulatory framework is tested, including country-specific regulations (i.e, fda or ema)..

We also recommend leaning on your community! Thousands of ACRP Certified members have been in your shoes. They are active community members and always willing to share tips and advice for ACRP exam prep.

Visit the acrp community >.

ACRP offers a variety of training and continuing education programs focused on the key ICH guidelines covered in the CCRA ® exam.

Learn more >.

Exam results are shared immediately at the conclusion of your exam, but PSI will send you an email with your full score report within 24 hours.

Your acrp account will reflect your results within 3 weeks of your exam date..

Congratulations! You just passed a major milestone on your professional journey and are now a member of the elite club of ACRP Certified clinical research professionals.

Keep an eye on your email because you will soon receive information from our digital badging partner credly about claiming your digital badge and how you can use it to tout your accomplishment. also learn how to use your new credential by reviewing the  certification mark policy ., you have 2 years to keep your certification in good standing by continuing your professional development, and we’ll be right there with you every step of the way. in the meantime, we highly recommend you review all the details about maintenance of certification . don’t leave it to the last minute.

Don’t worry. It happens to the best of us. Give it another try!

Refer to your acrp certification examination results email or the acrp certification handbook for guidance on the next steps in your certification journey., upcoming testing dates, spring 2024 testing february 15 – may 15, 2024, fall 2024 testing july 15 – october 15, 2024, 2024  registration dates and fees, early bird registration acrp members – $435 nonmembers – $485 spring 2024:  october 15 – december 31, 2023 fall 2024:  may 15 – july 15, regular registration acrp members – $460 nonmembers – $600 spring 2024:  january 1 – april 30 fall 2024:  july 16 – september 30, join acrp & save, joining acrp helps you save money. more importantly, acrp is where you will find the very best of what you need to design a career path that’s uniquely your own. connections through an engaged community. growth through gold-standard training. and elevation through rigorous certification., explore membership >, exam preparation, congratulations on your decision to earn the most recognized and respected endorsement of clinical research competency — acrp certification. as you start this important journey in your career, we’re here to support you every step of the way..

Thanks for starting your application to {{companyName}}.

To complete your application you must do one of the following:

Forward an email from your mobile device with your resume attached to {{fromEmail}}

Reply to this email from your laptop or desktop computer with your resume attached.

Thank you for your interest, The Recruiting Team

Reply to this email from your laptop or desktop computer with your cover letter attached.

In order to create an account with us and submit applications for positions with our company you must read the following Terms and Agreements and select to agree before registering.

In the event that you do not accept our Terms and Agreements you will not be able to submit applications for positions with our company.

You agree to the storage of all personal information, applications, attachments and draft applications within our system. Your personal and application data and any attached text or documentation are retained by Jibe Apply in accordance with our record retention policy and applicable laws.

You agree that all personal information, applications, attachments and draft applications created by you may be used by us for our recruitment purposes, including for automated job matching. It is specifically agreed that we will make use of all personal information, applications, attachments and draft applications for recruitment purposes only and will not make this information available to any third party unconnected with the our recruitment processes.

Your registration and access to our Careers Web Site indicates your acceptance of these Terms and Agreements.

Dear ${user.firstName},

Thanks for choosing to apply for a job with ${client.display.name}! Please verify ownership of your email address by clicking this link .

Alternatively, you can verify your account by pasting this URL into your browser: ${page.url}?id=${user.id}&ptoken=${user.token}

Please note that your job application will not be submitted to ${client.display.name} until you have successfully verified ownership of your email address.

The ${client.display.name} Recruiting Team

Nice to meet you. 👋

Lets quickly set up your profile

to start having tailored recommendations.

You agree to the storage of all personal information, applications, attachments and draft applications within our system. Your personal and application data and any attached text or documentation are retained by Sequoia Apply in accordance with our record retention policy and applicable laws.

This career site protects your privacy by adhering to the European Union General Data Protection Regulation (GDPR). We will not use your data for any purpose to which you do not consent.

We store anonymized interaction data in an aggregated form about visitors and their experiences on our site using cookies and tracking mechanisms. We use this data to fix site defects and improve the general user experience.

We request use of your data for the following purposes:

Job Application Data

This site may collect sensitive personal information as a necessary part of a job application. The data is collected to support one or more job applications, or to match you to future job opportunities. This data is stored and retained for a default period of 12 months to support job matching or improve the user experience for additional job applications. The data for each application is transferred to the Applicant Tracking System in order to move the application through the hiring process. \nYou have the right to view, update, delete, export, or restrict further processing of your job application data. To exercise these rights, you can e-mail us at [email protected] . \nConversion Tracking \nWe store anonymized data on redirects to the career site that is used to measure the effectiveness of other vendors in sourcing job candidates.

Consent and Data Privacy

This application protects your privacy by adhering to the European Union General Data Protection Regulation (GDPR). Jibe will not use your data for any purpose to which you do not consent.\n

We request use of your data for the following purposes:\n \n User Authentication \n

\n This site retains personally identifiable information, specifically e-mail addresses, as a necessary part of user login. This data is retained for the duration of the user profile lifecycle and enables user authentication.\n

\n \n Usage Analytics \n

We store anonymized usage data to measure and improve the effectiveness of this CRM application in filling job requisitions and managing talent communities.\n

\n \n E-mails to Candidates \n

We collect your personal information such as name and email address. This information is used when you send marketing or contact emails to candidates.\n\n

Enter your email address to continue. You'll be asked to either log in or create a new account.

There was an error verifying your account. Please click here to return home and try again.

You are about to enter an assessment system which is proprietary software developed and produced by Kenexa Technology, Inc. The content in this questionnaire has been developed by Kenexa Technology, Inc., Kenexa’s Suppliers and/or Yum Restaurant Services Group, Inc.’s (“Company”) third party content providers and is protected by International Copyright Law. Under no condition may the content be copied, transmitted, reproduced or reconstructed, in whole or in part, in any form whatsoever, without express written consent by Kenexa Technology, Inc. or the applicable third party content provider. Under no circumstances will Kenexa Technology, Inc. be responsible for content created or provided by Company’s third party content providers.

IN NO EVENT SHALL KENEXA, AN IBM COMPANY, KENEXA’S SUPPLIERS OR THE COMPANY’S THIRD PARTY CONTENT PROVIDERS, BE LIABLE FOR ANY DAMANGES WHATSOEVER INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF VOCATIONAL OPPORTUNITY ARISING OUT OF THE USE OF, THE PERFORMANCE OF, OR THE INABILITY TO USE THIS KENEXA ASSESSMENT SYSTEM OR THE CONTENT, REGARDLESS OF WHETHER OR NOT THEY HAVE BEEN ADVISED ABOUT THE POSSIBILITY OF SUCH DAMAGES.

By clicking below, you are also confirming your identity for purposes of the questionnaire. You may not receive assistance, refer to any written material, or use a calculator (or similar device) while completing the questionnaire.

Unless otherwise directed by the Questionnaire Administrator, you are only authorized to take each requested questionnaire once. Failure to comply may result in disqualification. All Kenexa SelectorTM questionnaires are monitored.

A web browser is a piece of software on your computer. It lets you visit webpages and use web applications.

It's important to have the latest version of a browser. Newer browsers save you time, keep you safer, and let you do more online.

Try a different browser - all are free and easy to install. Visit whatbrowser.org for more information.

If you are using a later version of Internet Explorer, please make sure you are not in compatibility mode of an older version of the browser.

• Medpace.com Home
• Search Jobs
• About Medpace
• Explore Careers
• Life at Medpace
• My Career Portal

Cookies are used on this site to assist in continually improving the candidate experience and all the interaction data we store of our visitors is anonymous. Learn more about your rights on our Privacy Policy page.

Skip to job results

Skip to refine results

• Skip to main menu
• Skip to user menu

Clinical Research jobs in Germany

• Refine results

Broaden your search

• Germany 162

Refine your search

• Hessen   4
• Baden-Württemberg   1
• Bayern   1
• Clinical Operations   9
• Clinical Research Associate   9
• Study Site Coordinator   4
• Clinical Development   2
• Clinical Trials Manager / Administrator   2
• Study Start Up   2
• Clinical Project Manager   1
• Clinical Research Nurse   1
• Clinical Research Scientist   1
• Euros   33
• GBP   2
• Full Time   35
• Permanent   35
• Recruitment Consultant   4
• Direct Employer   31
• Experienced (non-manager)   33
• Management   2
• CRA   11
• CTM   3
• CTA   2
• Project Manager   2
• CPM   1

Found 35 jobs

Clinical research manager, crm home based role in germany.

• Munich, Germany
• Competitive

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortre...

View details Clinical Research Manager, CRM home based role in Germany

• Save Clinical Research Manager, CRM home based role in Germany You need to sign in or create an account to save

Clinical Research Associate, sponsor dedicated

• Germany, Homeworking
• ICON Strategic Solutions

The Clinical Research Associate will perform site activities for Phase I-IV studies operating as the main point of contact for the site during a study

View details Clinical Research Associate, sponsor dedicated

• Save Clinical Research Associate, sponsor dedicated You need to sign in or create an account to save

Amplity Health - Join Our Talent Community in Germany

• Amplity Health

Come join the true partner of global healthcare companies, Amplity Health. We continually challenge the boundaries of medical and commercial strate...

View details Amplity Health - Join Our Talent Community in Germany

• Save Amplity Health - Join Our Talent Community in Germany You need to sign in or create an account to save

• France, Germany

We are constantly looking for motivated, reliable and dedicated CTAs who can demonstrate a first experience as a Clinical Trial Assistant, Study Coord

View details CTA

• Save CTA You need to sign in or create an account to save

Experienced Clinical Research Associate (m/w/d), Multi-Sponsor

• Frankfurt/Main

Join IQVIA as a CRA / SrCRA (m/w//d) in our Clinical Site Management department home-based throughout Germany. You will focus on a comprehensiv

View details Experienced Clinical Research Associate (m/w/d), Multi-Sponsor

• Save Experienced Clinical Research Associate (m/w/d), Multi-Sponsor You need to sign in or create an account to save

Clinical Research Associate (m/w/d), Single Sponsor

When you join IQVIA as a sponsor-dedicated Clinical Research Associate / CRA (m/w/d) home-based throughout Germany, you’ll enjoy the stability

View details Clinical Research Associate (m/w/d), Single Sponsor

• Save Clinical Research Associate (m/w/d), Single Sponsor You need to sign in or create an account to save

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission

View details IHCRA

• Save IHCRA You need to sign in or create an account to save

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research provid

View details SMA I

• Save SMA I You need to sign in or create an account to save

Associate Director, Study Start-Up

We are seeking a key manager to support the Medpace Study Start-up group in Europe while being office-based in Munich. This position will be an int...

View details Associate Director, Study Start-Up

• Save Associate Director, Study Start-Up You need to sign in or create an account to save

Entry Level Contract Specialist

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based and hybrid Contract Specialist to jo...

View details Entry Level Contract Specialist

• Save Entry Level Contract Specialist You need to sign in or create an account to save

Create a job alert and receive personalised job recommendations straight to your inbox:

Local Clinical Trial Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovat

View details Local Clinical Trial Manager

• 11 days ago
• Save Local Clinical Trial Manager You need to sign in or create an account to save

Clinical Research Associate - Sponsor Dedicated

View details Clinical Research Associate - Sponsor Dedicated

• 12 days ago
• Save Clinical Research Associate - Sponsor Dedicated You need to sign in or create an account to save

Clinical Site Manager

View details Clinical Site Manager

• 13 days ago
• Save Clinical Site Manager You need to sign in or create an account to save

Senior Clinical Research Associate (m/w/d), Single Sponsor

Join IQVIA as a Senior Clinical Research Associate / Sr CRA (m/w/d) home-based throughout Germany in our single sponsor department, and advance

View details Senior Clinical Research Associate (m/w/d), Single Sponsor

• 16 days ago
• Save Senior Clinical Research Associate (m/w/d), Single Sponsor You need to sign in or create an account to save

Clinical Research Associate or Senior CRA (m/w/d), Boehringer Ingelheim Projects

We are looking for an experienced CRA or Senior CRA (m/w/d) for a sponsor dedicated role in cooperation with Boehringer Ingelheim, one of the l

View details Clinical Research Associate or Senior CRA (m/w/d), Boehringer Ingelheim Projects

• Save Clinical Research Associate or Senior CRA (m/w/d), Boehringer Ingelheim Projects You need to sign in or create an account to save

Study Start Up Associate I

• Estonia, Germany, Homeworking

Study Start Up Associate I - German and English Language Fluency At ICON, it's our people that set us apart. Our diverse teams enable us to become a b

View details Study Start Up Associate I

• 18 days ago
• Save Study Start Up Associate I You need to sign in or create an account to save

Clinical Study Nurse

• Tübingen, Germany

Tübingen, Germany Are you interested in working directly for a single sponsor while having the security and additional career opportunities that wo...

View details Clinical Study Nurse

• 20 days ago
• Save Clinical Study Nurse You need to sign in or create an account to save

Clinical Research Manager - Integrative Onkologie

• Germany, Baden-Württemberg
• EUR70000 - EUR100000 per annum
• i-Pharm Consulting

Position: Clinical Research Manager - Integrative Onkologie Ort: Tübingen Umgebung (Hybrid) Sind Sie sich sicher, dass Sie auch wirklich den Job habe

View details Clinical Research Manager - Integrative Onkologie

• 22 days ago
• Save Clinical Research Manager - Integrative Onkologie You need to sign in or create an account to save

As Clinical Site Manager you will be responsible for maximizing site performance and site engagement in our client conducted clinical studies, as well

• 5 days left
• 4 days left

Clinical Research Associate: A Full Guide on Becoming A CRA

Clinical Research Associate

A complete guide on how to become a clinical research associate.

Over 1.9 million students receive a bachelors of science every year. While a few go on to PhD, Masters, and Medical programs; many are ready to start clinical research certification online to start a career in the frontiers of medical research and patient care.

As a new student applying to the science job market, you may only find internships or recognize that even entry-level science jobs requires 1-2 years of experience. More so, you may realize many of these jobs require intense labor in the lab or just did not meet your expectations for your science degree.

This is why a career as a CRA should be considered with clinical research coordinator training. We train over 500 students each month in clinical research coordinator training and clinical research associate training (depending on prior background).

For those who have always wanted a career in medicine or have a gap year before medical school; Clinical Research Training is the next step to getting a head start in your career.

Because the position is unlike actually working in the lab and more of a management role; you get 1-on-1 connections with physicians and medical staff that can lead to a better application for medical school and other medical careers later on.

Best of all; many of these positions accept remote staff (and some allow you to travel 45-75% with full expenses including travel, accommodation, meals, and other per-dime expenses covered).

Clinical Research Training can help you save money while also increasing your salary. CRA’s with our level of training can expect to make between $6,500-$12,000 a month with an estimated promotion rate of 33% a year: an amount that is uncommon in other science-degree careers.

CCRPS is one of the only major US-based ACCRE, ACCME, ANCC, ACPE, and Transcelerate Biopharma accredited CRA certification courses that accepts students with no prior background for certification. T

his is because our course is thorough and created by Senior CRAs who have been in the field for long enough to understand what you need to know to begin working and applying. The course can be completed in as little as 7 days with dedicated full-day study time.

Clinical Research Associate Certification Qualifications

A Clinical Research Associate or Coordinator directs and supervises clinical trials that are run by physicians, nurses, and other science-degree holders.

Many CRA students are actually matriculated foreign doctors who opted not to take the USMLE or repeat their residency training. In fact, some of our Clinical Research Training Students come to us immediately after moving to the U.S. wondering what to do with an MBBS degree in US.

Unlike what you’ve learned during your 3-8 years in university or graduate school, Clinical Research Training after your degree is rarely a repetition of any course you’ve taken before.

Thus, we have 110 Clinical Research Training modules (more than any other course available) to make sure you get the position you want as a CRA.

Unlike the jobs you currently can apply to on the market, a position as a CRA is actually much more difficult to obtain.

While many generic courses exist on the market; we have seen that many of these students cannot find a job afterwords because of the lack of content depth. This is why our course offers a Senior Clinical Research Associate level of training with 110 intense modules.

This science-based medical position is now a high-demand job which can be done privately for pharmaceutical companies such as Pfizer, or academically in medical schools. In addition, we have the largest number of clinical research courses online.

Why Take A CRA Certification Course

 The role of the clinical research associate is to ensure that medical devices, new treatments and new drugs are approved for patients' use.

This field is taken as a certificate program course in many schools. For example, you may find associate degree programs. These programs can be completed in two years and can be offered through both the online and the hybrid formats. Hybrid formats combine both online and on-campus courses together.

If you opt for a fully online program, you can still get an immersive education. Different platforms like emails and discussion boards are used to ensure and promote interaction between the students as well as the lecturers.

Online learning platforms are used to upload the syllabus, course materials, lectures and assignments. Some online programs include field work as part of their requirements, in order for students to gain first hand experience working with clinical trials and patients. Depending on the school, they may have a list of approved clinical research institutes and other facilities. Otherwise, you will have to find a facility for yourself and get the school's approval.

These certificate programs are generally designed for professionals that are already in the medical fields (like medical assistants or nurses) and are interested in moving to the field of clinical research.

They may therefore ask for a copy of your CV or resumé or they may ask for a letter from your employers to verify that you have the needed medical experience. Some programs may require just an undergraduate degree in a medical science or life science related field.

Clinical research associates are trained to assist clinical researchers and investigators in the coordination, administration and management of clinical trials.

During this training, different courses will be taught revolving around subjects like safety procedures, subject recruitment, regulatory requirements, drug development, accountability, trial management, medical terminology etc.

The importance of the role of the clinical research associate means that companies that conduct clinical trials are usually very selective. The need to comply with strict regulations often inform their decision when making a choice of their clinical research associate. It is therefore very difficult to get a job as a clinical research associate without previous experience in clinical trials.

Many companies require around at least two years experience in clinical monitoring as a clinical project assistant or clinical trial administrator before considering applicants for this important role.

In applying for the post of a clinical research associate , ensure that you read the job description and indicate or highlights the relevant experience on your curriculum vitae. Your cover letter should be specific to the company you're applying to.

Do not use a one-for-all cover letter. Personalize your cover letter to each company and highlight the skills that fit the specific requirements of the role. Not all companies advertise their vacancies, so you can try to find out about other unadvertised vacancies, you might increase your chances.

Further certification can enhance your resume such as the ACCRE accredited CRA program which contains 110 learning modules for Clinical Research Associate Training and Placement

The Best CRA Certification Course For Entry-Levels

There is a huge shortage of well-trained CRAs, but many companies are reluctant to hire untrained entry-level clinical monitors because of patient and trial safety. Because of this, even the beginner entry-level jobs require certification or training.

Our program is considered one of the top clinical research graduate programs online. Most courses provide very light training that may look good because of the company names, but alone is not sufficient to pass the interview rounds a company conducts.

Because our modules are prepared help even Senior Clinical Research Associates, we find more of our students with no background quickly passing their interview rounds.

CCRPS Course covers double to triple the amount of course content than other courses. While many courses are simply 5-20 simple interactive modules, our course covers 140 dense modules in thorough detail.

After each session, students can ask their questions privately with the course instructor, all of whom have 15+ years of CRA experience.

Currently, 82% of our students are hired within the first month of taking the course. Students with limited background or those looking to gain extra experience are offered a remote internship of up to 6 months during the time they are interviewing.

This advantage allows many students with limited experience to get hired with a higher paying job than previously offered.

While a majority of our students are physicians, a majority of the CRA workforce are Science Grads and Nurses. nonetheless, we train all students at a Senior CRA level regardless of background because clinical research monitoring is vastly different from any lab or science course you may have taken.

Clinical research associates are given the protocol of a study including all medical protocol that must be followed but because they do not diagnose or treat. Medical knowledge is supplemental but not sufficient in this career path.

This is the main reason why our Clinical Research Training includes all possible scenarios you may face at the protocol and guideline level in your future company.

How To Get Experience For Clinical Research Associate Jobs

CCRPS, like other educational institutes, is only associated with educating and certifying clinical research professionals so we do not provide job placement. We want to make sure you apply with your best foot forward. Below are links we readily refer to graduates who are looking for job support. Having a great CV and cover letter are essential to applying for jobs. Recruiters are paid by the company which hires you and thus are free for searching employees. Be realistic but also be driven. Make sure you get continue reaching out until you get a true rejection from any job you apply to as they may never have seen your application if you received no response.

Clinical Research Job Advising: Kunal at ClinicalTrialPodcast

Free Resume Review: TopCV TopCV provides a free review and feedback for your current resume.

Resume Distribution: ResumeRabbit Resume rabbit distributes your resume to 60 job posting sites.

Clinical Research Recruiters: I-Recruit I-Recruit distributes your resume to clinical research recruiters.

Clinical Research Job Bulletin: Indeed Indeed usually provides the most uptodate job bulletin for clinical research jobs

Always use a cover letter specific for the company and job when applying if you are not using a recruiter.

The ICH-GCP in Clinical Research

Regardless of the type of clinical research or function of an IP being tested, it is important that clinical research should meet two critical criteria:

The clinical research process should respect the rights, freedom and dignity of tested patients (human participants).

Data from the clinical research process should be accurately collected, safely stored, rigorously scrutinized and correctly interpreted.

One way to ensure that these requirements are met is to follow a set of internationally recognized and accepted standards for clinical research. 

Most countries across the world today follow ICH-GCP, that is, International Committee for Harmonization of Good Clinical Practice guidelines in conducting clinical research on human participants7.

The ICH-GCP outlines procedures and precautions that are essential in order to protect the safety and wellbeing of human research participants during clinical research, and to ensure the integrity of data from clinical research studies.

In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’8.

In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’8.z

Qualifications and Qualities of a CRA

According to the International Accrediting Organization for Clinical Research (IAOCR), candidates for CRA positions usually hold either a biological science degree, or one in medicine or nursing10. 

The New Scientist recommends that aspiring CRAs should possess a good working knowledge of one or more of the following subjects – anatomy, biology, biochemistry, chemistry, immunology, microbiology, pharmacology, physiology or toxicology11.

In addition to a background in medical or life sciences, a CRA is required to have a good grasp of data management, including Electronic Data Capture (EDC), data analytics and reporting12.

Sketching the CRA work profile, the authors Diane St. Germain and Marjorie Good state that CRAs are the ones who scrutinize clinical study data most closely from start to finish—as a result, they are often the first to notice critical patterns and interesting trends, and to report these to the research team as well as to the CRO13.

Equally if not more importantly, a CRA must possess a high level of emotional and interpersonal savvy. This is a crucial area, since a CRA’s success hin ges upon his/her ability to elicit the best from team members, in terms of both performance and probity. 

Core Competency Framework for CRAs

To illustrate, the ACRP’s ‘Core Competency

Framework for Clinical Study Monitoring’

requires that a CRA should be able to identify

and correct compliance violations at a study

site. The CRA must not only bring such

violations to the attention of site staff, s/he

must induce them to take corrective action,

as well as reporting the matter and even

escalating it, where necessary14.

The table below summarizes the ideal

competencies of a CRA, and provides

insights on how each ability contributes to

the CRA’s performance.

CRA Career Path

In the past, CRA positions were often filled by individuals with medical or nursing backgrounds, with little thought given to their lack of research training15. As awareness grew about the importance of research experience for a CRA, employers began preferring those with years of experience in clinical research settings, such as Clinical Trials Assistants (CTAs) and Clinical Research Coordinators (CRCs)16.

However, in recent years, the focus has shifted once again from a tenure-based mindset to a skills-based evaluation17. In part, this change has been brought about by the growth in professional courses and training programs in the field. 

For instance, many leading US Universities today offer master’s programs in clinical research18. In addition, there are some widely recognized certification programs for clinical research associates, such as those offered by the ACRP19 and the Society of Clinical Research Associates (SOCRA) 20.

Note: You must already be working as a CRA to qualify for the ACRP and SOCRA certification programs.

A Toe in the Door: CRA Certification for a Non-CRA

By this point, you might be wondering, “I have no research experience… I’ve never worked as a Clinical Trials Assistant (CTA) or a s a Clinical Research Coordinator (CRC). Nor do I have a degree in Clinical Research. Can I still become a CRA?”

The simple answer is, yes, you can.

You might be a life sciences graduate looking for a lucrative career in the pharmaceutical or biotechnology sectors. Or, you’re excited by a career in research, but unsure whether the drudgery of a Ph.D. is your thing.

Maybe you’re just looking for a job that represents a great option for someone with your combo of science background plus detail-orientedness.

Whichever of these descriptions best applies to you, a career as a Clinical Research Associate could be exactly right for you.

With the right training, you can be recruited directly to a Clinical Research Associate position, even without a background in clinical research.

So, what kind of training will help me break through the ‘experience’ barrier and land a job as a CRA?

As you’ve already gathered from the table, the skill-set required to be a successful CRA is pretty extensive.

Aside from an in-depth knowledge of scientific and medical concepts and principles, a CRA must have a sound grasp of medical research regulatory requirements, a penchant for being thorough and systematic, as well as a knack for coordinating and managing people with diverse skills, roles and backgrounds.

To our knowledge, CCRPC’s ‘Advanced Clinical Research Associate Certification’ (ACRAC) is one of a kind: The ACRAC is the only multi-accredited* certification program in the US that offers the kind of exhaustive as well as intensive training that equips candidates from a non-clinical background with the abilities and competencies that make a good CRA.

Best of all? The ACRAC is open to fresh graduates holding a B.S. degree in any of the life sciences, with no requirement for prior exposure or experience in clinical research.

*The ACRAC program offered by CCRPC is accredited to ACCRE (Accreditation Council for Clinical Research & Education), ACCME (Accreditation Council for Continuing Medical Education), ACPE (Accreditation Council for Pharmacy Education), ANCC (A merican Nurses Credentialing Center), as well as Transcelerate Biopharma.

Training to be a CRA through CCRPS ACRAC

The ACRAC program includes over 100 course modules that cover all the important knowledge domains and skill-sets required by a CRA.

Designed for a total study time of approximately 250 hours, this training program can be completed at your own pace, or, for those able to dedicate the whole day to study, in as little as two to three weeks.

Starting with a broad overview of clinical research jargon and terminology, the course walks students through the principles of Good Clinical Practice, familiarizing you with the relevant sections of the ICH-GCP and the FDA’s E6(R2).

The program places particular emphasis on ethical practices in research with vulnerable populations.

Students going through the ACRAC are trained in all major aspects of designing a Clinical Trial Protocol in keeping with the Code of Federal Regulations (CFR).

They additionally learn the steps involved in the IRB/IEC approvals process and how to prepare required documents.

Finally, students become aware of the importance of pharmacovigilance and the regulatory process for new drug testing.

A major chunk of the ACRAC certification centers around equipping the CRA for day-to-day responsibilities, such as different types of site visits – preliminary (Site Qualification), preparatory (Site Initiation) and progress monitoring visits (Routine Monitoring).

Crucially, the ACRAC covers essential documentation such as the Case Report Form and Trial Master File, as well as electronic data capture (EDC) and remote monitoring systems.

A vital component of the training program involves empowering students to tackle challenging situations.

For a CRA, these include identifying protocol deviations and violations, and recognizing as well as reporting research fraud and ethical misconduct.

In addition to its comprehensive coverage, the ACRAC certification offers the great advantage of including 17.5 CME credits – that is, course credits that count towards ‘Continuing Medical Education’.

These credits can be used by individuals desiring to further their education and/or careers in healthcare-related fields, including medicine, nursing, pharmacy and research.

Clinical Research Associate Training

Get ahead in clinical research with advanced accredited online CRA certification for $450. Demo our on-demand course below.

Clinical Research Associate Certification

Advanced clinical research associate certification (acrac).

Chapter 1: Introduction

This chapter orients you to the concept of Continuing Medical Education (CME) and outlines how the CCRPS CRA program contents meets AMA requirements for CME. Given that, across the US, physician practitioners are required to complete between 20 and 50 hours of CME credits yearly, the ACCME-accredited CCRPS CRA course can be used not only to build knowledge and skills in the field of clinical trial management, but also to further a successful medical career. Additionally, the introductory chapter introduces you to the clinical terminology and abbreviations commonly encountered in clinical research, for example, Investigational Product (IP), Good Clinical Practice (GCP), Institutional Review Board (IRB) and so on. 

Chapter 2: Roles and Relationships in Clinical Trials

The unit presents the foundational background to beginning and building a career as a clinical research associate (CRA). As you know, a CRA plays a critical role in setting up as well as monitoring the clinical trials process for an investigational product or IP – a medical drug or device under development. In this unit, you will learn how a CRA interacts with other stakeholders, including the Clinical Research Organization (CRO) or Sponsor of the clinical trials, the Principal Investigator (PI) as well as other research site staff, the trials monitoring team including the Clinical Research Coordinator (CRC),other CRAs and the Data Safety Monitoring Board (DSMB), as well as the research ethics committee (Institutional Review Board or IRB).

Chapter 3: Sponsor and Investigator Roles

In this unit, you will gain insight into the ICH-GCP guidelines, particularly addendum E6, sections 2 through 5, which outline procedures and precautions essential for protecting the safety and wellbeing of human research participants during clinical research. These include guidelines for obtaining informed consent from human subjects, maintenance of trial records, reporting of compliance, safety and research progress, as well as procedures for suspension or termination of the trials process. The chapter familiarizes you with the critical importance of monitoring for Adverse Events (AEs), including types of AEs and regulations for documentation and reporting.

Chapter 4: Clinical Trial Design

In this chapter, you will acquire insight into the different phases of the clinical trials process, from the pre-clinical phase through Phases 0 to 4 of clinical testing. The unit will familiarize you with important concepts of clinical trials, such as the structure and goals of each phase of clinical trials, approaches to dosing, toxicology of pharmaceutical products, in vitro and in vivo testing, dose escalation and so on. Finally, the chapter reviews the FDA’s drug approval process.

Chapter 5: ICH-GCP – Overview

The chapter dives deep into GCP, including a review of the history of medical research leading up to the ICH-GCP. The unit covers all four QSEM categories of the guidelines for ensuring Quality, Safety and Efficacy of the IP, as well as  Multidisciplinary guidelines (mainly pertaining to documentation and electronic data safety standards). In addition, the chapter includes an overview of MedDRA software that provides a standardized system of terminology and notation for documenting clinical research, as well as principles of budgeting for clinical trials.

Chapter 6: Ethical Research in Vulnerable Populations

The unit provides a detailed walk-through of the regulations and compliance requirements for conducting clinical trials with human subjects who meet the definition of a ‘vulnerable population’, including pregnant women and fetuses, children, mentally incapacitated individuals (those with cognitive functioning impaired by neurolopsychological conditions or chronic substance abuse), as well as prisoners. You will acquire familiarity with the challenges of research in such populations, including the requirement for parental consent, fair but not excessive incentive, justifiable deception or incomplete disclosure, coercive practices and so forth.

Chapter 7: Adverse Events

Through this module, you will gain a bird’s eye view of the protocol for documenting, reporting and responding to AEs or adverse events during the clinical trials process. The unit covers concepts such as expectedness, severity and seriousness of AEs, Adverse Drug Reactions (ADRs) as a sub-category of AEs, Investigational New Drug or IND reports, causality analysis for AEs and so on. In addition, the chapter reviews the responsibilities of both research sponsors as well as IRBs in sharing AE information with subjects. 

Chapter 8: Clinical Trial Protocol

The chapter provides an in-depth tutorial on the structure and elements of a CTP or clinical trial protocol, as well as guidelines on writing a CTP. Important concepts reviewed include study Risk Benefit Analysis (RBA), study sample statistics (sample size, statistical power, plan for data analysis), risk management and study administration. Additionally, the module covers concepts central to study sample selection, addressing inclusion and exclusion criteria, especially safety and ethics considerations in sampling. 

Chapter 9: Protocol Deviations and Violations

Through this unit, you will gain familiarity with the many potential causes of protocol deviations and violations, learning to distinguish between minor (deviations) and major departures or violations of protocol. Content provides understanding of the most commonly occurring violations, including both minor (off-schedule subject assessments, subjects’ use of prohibited drugs, and so on) as well as major violations (failure to obtain informed consent, failure to report AEs and so forth). Further, the chapter reviews principles for reporting protocol deviations, IRB approval for planned deviations and related concepts. 

Chapter 10: IRB and DSMB

This chapter briefly reviews the history of IRBs and examines the principles guiding IRB decision-making. In addition, the unit discusses recent developments in compliance, including sIRB (single IRB) and SmartIRB for institutions that are part of the CTSA (Clinical and Translational Science Awards). The bulk of this module dives into the categories of IRB review, including full board and expedited review, examining criteria for review exemption such as educational or purely behavioral research, as well as studies collecting identifiable data, surveys and interviews.   

Chapter 11: Review Questions

The module provides a self-assessment tool by including questions that review the content covered in previous chapters. The set of 71 questions examines all aspects of ICH-GCP previously discussed.

Chapter 12: Site Monitoring Visits

In this module, an overview is provided of the different types of site monitoring visits, including site selection or qualification visit, study initiation visit, routine or progress monitoring visit, as well as study termination or close-out visit. Important concepts discussed include pre-qualification preparations and site feasibility assessment as well as study monitoring criteria (data omission, incorrect entries, inaccurate calculations, documentation of corrections and so on). For each type of site monitoring visit, the chapter reviews relevant documentation.

Chapter 13: Site Qualification Visit (SQV)

The chapter gives an in-depth understanding of the stages and steps involved in selecting a study site. Elements reviewed within the module include the process of investigator selection and criteria for site evaluation (the four P’s: Patient, Protocol, Performance, Profit). Importantly, the module reviews the most common errors in feasibility assessment, including overestimation of sample availability at site, selection of site staff with low motivation, poor-performing sites owing to high competition for personnel and resources (for example, owing to multiple studies running on a single site), and so on.  

Chapter 14: Site Initiation Visit (SIV)

The module dives into the details of an SIV or site initiation visit. You will review the procedure for pre-SIV preparation, including filing for IRB and other necessary approvals, permits and licenses. Additionally, the chapter examines elements of the SIV agenda, mainly orientation and training of site staff, creation of important study-related documents such as the Trial Master File (TMF) and post-SIV filing of compliance documents such as FDA form 1572 and Financial Disclosure Form (FDF) for relevant site personnel. 

Chapter 15: Routine Monitoring Visit (RMV)

In this unit, the elements of a routine or periodic monitoring visit are discussed in detail. You will become familiar with the agenda of an RMV, which prioritizes receiving updates on AEs from site staff (incidence, documentation, seriousness and so on), as well as oversight of the overall progress of trials. The chapter covers different approaches to site monitoring, contrasting traditional (full-scale) monitoring with risk-based monitoring (RBM), as well as comparing on-site monitoring with remote monitoring. A crucial concept addressed by the unit is Source Data Verification (SDV), which is central to obtaining meaningful, high-quality data from clinical trials.

Chapter 16: Site Close-Out Visit (SCOV)

The module gives you a comprehensive overview of the protocol and procedures involved in terminating or closing out a trial site. Aspects covered in the chapter include pre-SCOV preparations such as IRB notification and schedule coordination among site staff (PI, other investigators, medical staff) and monitoring team (CRC, CRAs and so on), agenda for an SCOV – drug inventory management, database verification and lockdown, subject intimation and completion of all subject-related documents, staff-related documentation as well as other administrative tasks including close-out report compilation.

Chapter 17: Tools for Monitoring Visits

This unit outlines a host of tips and tools that can help a CRA in successfully tackling the complex process of monitoring clinical trials. The chapter lists numerous physical accessories you can use for effective monitoring, including scheduling and calculation aids, ready reckoners for drug information and medical terminology, as well as document templates to speed up the process of obtaining trial updates while also serving as checklists for the site visit agenda. Additionally, the unit highlights helpful strategies that a CRA can use to ensure that site visits go smoothly, from travel advice to team-building suggestions. 

Chapter 18: Audit and Inspections

The module deals with one of the most crucial and often most feared aspects of a CRA’s career – audits and inspections by the CRO (sponsor), FDA or other regulatory authority. Starting from the basic distinction between an audit and an inspection, the chapter covers in detail the protocols for both audits and inspections. Crucially, the chapter will enable you to grasp the difference between a routine audit/ inspection and a ‘for-cause’ audit/ inspection. Further, it lays out the sequence of an FDA inspection in full (including a detailed walk-through of the FDA BIMO or Biomedical Research Monitoring Program inspection), and provides important guidelines on the do’s and dont’s for CRAs during an audit/ inspection, such as the critical ‘3 to 5 minute rule’. You will acquire familiarity with important audit and inspection-related documents such as FDA Form 482 (Notice of Inspection) and Form 483 (Notice of Observation) as well as the Establishment Inspection Report (EIR) prepared by the auditor/ inspector. Finally, you will gain insight into the classes of observations provided in an EIR, including NAI (no action indicated), VAI (voluntary action indicated) and OAI (official action indicated)—the last is commonly termed an ‘FDA warning letter’.

Chapter 19: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of clinical trial quality monitoring, including monitoring visits, tools as well as audits and inspections.

Chapter 20: SDV and Informed Consent

In this chapter, the ICH-GCP section 4.8 guidelines on obtaining informed consent from subjects are discussed in detail, highlighting the need for using non-technical language, transparent delineation of risks, consent without undue influence, obtaining consent (and assent) from minors and their Legally Acceptable Representatives (LARs), as well as consent from non-English speakers and sedated subjects. The chapter additionally covers important aspects of Source Data Verification (SDV) with respect to electronic as well as paper-based medical records, and highlights the central goal of SDV, which is to conform to ICH-GCP requirements that subject trial data (as recorded in Case Report Forms or CRFs) must correspond to source data (previous medical records).

Chapter 21: Case Report Form

The module provides an in-depth tutorial on the structure and elements of a Case Report Form or CRF, including the different forms for PI verification, subject enrollment, eligibility and randomization, medical history, physical examination and laboratory data, compliance, adverse events and so on. In addition, the chapter outlines important data notation rules, such as the use of accepted acronyms (‘ND’ for missing data and ‘UNK’ for unknown information, MM-DD-YY format, time-stamp data and so forth), as well as guidelines for the design of CRFs (such as consistency of notation, avoidance of data fields that can be computed and of duplicate data fields and so on).

Chapter 22: Quality Control and Safety

Within this unit, you will learn the central concepts of Quality Control (QC) in the context of clinical trials, including definitions of QC and its relationship with the complementary process of Quality Assurance (QA), the use of Key Performance Indicators (KPIs) in QC, need for a Corrective and Preventive Action (CAPA) plan and so on. Additionally, the module examines the QA process, focusing on the central role of RBM or risk-based monitoring in present-day QA as well as providing guidelines on Quality Metrics (QMs) for evaluating the trials process. The chapter also reviews ICH-GCP guidelines on subject safety, underlining risk-benefit assessment, stoppage rules (for instance, in case of SAEs) and reporting responsibilities. Finally, it introduces the FDA’s Human Research Protection Program (HRPP) as a platform that provides training and support for personnel involved in clinical trials.

Chapter 23: Technology in Trials

In this chapter, an in-depth tutorial is provided of the systems used in modern clinical trials for Electronic Data Capture (EDC) and database management. Systems such as Interactive Response Technologies (IRTs) including IVRS and IWRS (Interactive Voice and Web Response Systems, respectively) as well as RTSM systems for Randomization and Trial Supply Management are examined.  The unit reviews the benefits of standardized data management and data sharing, approaches to database management and the concept of an Independent Data Monitoring Committee (IDMC). Critical elements of data integrity, such as proper anonymisation and coding, completeness of data, data safety precautions and logging of site visits and other progress reports are highlighted. The unit further examines the essential features of a good Clinical Data Management (CDM) system that complies with FDA CFR Title 21 and HIPAA regulations, such as setting access privileges, tracking changes and updates, data security and locking, flagging and reconciliation of AEs and so forth. Finally, the chapter looks at CTMSs (Clinical Trial Management Systems) in depth, covering the aspects that allow management of day-to-day trials in multi-site studies. 

Chapter 24: Modernized Monitoring (Remote, Risk-based, Centralized)

 This chapter offers a detailed walk-through of modern, remote monitoring of clinical trials, which evolved into a full-fledged system in response to the COVID-19 pandemic. Important concepts discussed include the critical site initiation process, Electronic Source Data Verification (ESDV) and FDA regulatory guidance for remote monitoring of clinical trials. In this module, you will learn how FDA’s ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) criteria for data quality have been adapted to remote monitoring. Further, the unit discusses how HIPAA compliance in remote monitoring is achieved by using limited data sets (wherein sensitive individual information is concealed through anonymous subject codes) regulated by data use agreements. Finally, the unit examines how risk-based monitoring approaches have allowed centralized monitoring to evolve into a cost-effective and safe method for clinical trial monitoring.

Chapter 25: Pharmacovigilance and Regulatory Affairs

Through this unit, you will gain insight into the process and rationale behind pharmacovigilance (PV) and its central role in the clinical trials process. The chapter reviews the statistics on AEs, distinguishes between Type A and Type B AEs, and profiles seriousness of ADRs or Adverse Drug Reactions as well as the iGuard Drug Risk Rating System. Importantly, the unit covers ADR causality assessment in detail, including both severity and probability assessment. An important element of PV addressed in this module is the Individual Case Safety Report (ICSR), its structure, content and role in trial monitoring. Other concepts discussed include types of PV inspections (routine vs. ‘for cause’), PSURs or Periodic Safety Update Reports and study criteria for instituting DSMBs (Data Safety Management Boards). Finally, the module also reviews the domain of Regulatory Affairs (RA) as a function of PV, outlining roles and responsibilities of RA personnel as well as the importance of RA in streamlining the process of drug development by ensuring compliance throughout manufacturing, clinical trials, marketing and advertising.

Chapter 26: Investigational Product

In this chapter, an in-depth review is provided of the protocol for receiving, storing and dispensing the IP or investigational product. At every stage, guidelines lay down strategies for ensuring verifiability, accountability and safety of both study subjects and staff. Thus, IP handling precautions include the need for logging date of manufacture, temperature throughout transit, as well as batch number and individual unit numbers (such as bottle or tube identifiers) carefully and accurately, as well as recording shipping details and filing shipping receipts. Additionally, the unit addresses the need for IP dispensing precautions, such as limiting dispensation to authorized personnel only, as well as maintaining individual subject IP logs.

Chapter 27: Local and Central Labs

The module profiles the evolution of lab testing in clinical trials, from error-prone localized laboratory testing to centralized testing that allows homogeneity of testing procedures and measurements, thus minimizing errors and improving outcomes. The chapter reviews standards for clinical trial laboratories as per the GLCP (Good Clinical Laboratory Practice) and CLIA norms (Clinical Laboratory Improvement Amendments), as well as providing guidelines for lab audits, including fire safety, protective gear, staff training and so forth.

Chapter 28: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of trial documentation (SDV, CRF, ICSR), quality control, pharmacovigilance, as well as IP and lab guidelines.

Chapter 29: Regulatory Documents in Clinical Trials

The chapter reviews essential documentation to be created and maintained throughout the course of the clinical trials, including the Trial Master File (TMF), FDA forms 1571, 1572, 3674, 3454/3455 and CFR Title 21 Form 312, besides ethics approval documents such as the IRB-approved protocol, informed consent form, subject education and study advertising materials. You will acquire in-depth familiarity with each of these forms, and learn the importance of maintaining and updating records, for example by incorporating IRB revisions and amendments, periodic renewals of permissions and licenses and copies of submitted reports. In addition, the unit summarizes the need for filing documents outlining study- and site-specific procedures, including SOP (Standard Operating Procedure), MOP (Manual of Procedures), Investigator Brochure (IB), Delegation of Authority Log (DOAL), site staff CVs, SAE notifications, logs of subject screening and enrollment, IP storage (temperature, humidity, etc.) and all relevant study parameters.

Chapter 30: CFR Title 21 Part 11 – Electronic Signatures

This unit gives you an overview of Title 21 of the FDA Code of Federal Regulations (CFR), including Chapter 1 sections on informed consent (Section 50), IRB approval (Section 56) and so on, Series on food (100), pharmaceuticals (200 and 300) and so on, as well as FDA Drug Schedules. The major part of the module focuses on Part 11 which deals with Electronic Records and Electronic Signatures (ERES), laying down the criteria for determining safety and reliability (trustworthiness) of electronic data and signatures.

Chapter 31: New Drug Application

Through this module, you will gain knowledge of the FDA process for evaluating a drug under development, and the role of a CRA in streamlining this process. An important distinction covered here is the difference between an IND (Investigational New Drug) and an NDA (New Drug Application). The chapter discusses in-depth the criteria used in evaluating an IND, including toxicology and pharmacokinetics data, as well as requirements for different drug classes (oncology vs. non-oncology). Additionally, the unit covers FDA requirements for AE reporting, including assessment of seriousness, expectedness and format for expedited reporting of life-threatening SARs, as well as safety reporting requirements for investigators. 

Chapter 32: Trial Master File

The unit provides a detailed breakdown of the organization of a TMF or Trial Master File, listing the various binders that should be included within the TMF, as well as their contents. Thus, the TMF should contain binders pertaining to the study protocol and IRB, investigator qualifications, FDA forms and correspondence, FDFs or Financial Disclosure Forms, communications with the CRO, and other relevant trial aspects. A helpful templatic guide to creating a TMF is also provided in this chapter, as well as a self-assessment quiz of 10 items on important sections of a TMF. 

Chapter 33: Disclosures and Payments for PI, Site, Patients

In this chapter, FDA guidelines regulating financial disclosure are discussed in-depth, covering the definition of ‘conflict of interest’ and the stipulations of Title 21 Section 54 on disclosure requirements. The unit helpfully contrasts FDA requirements with Canadian and UK/EU policies. You will study real life case examples of conflict of interest, as well as lawsuits pertaining to financial disclosure disputes to help gain a better understanding of the potential problems arising from failure to disclose financial interests in clinical trials. Another important dimension covered in the module is the regulation of payments to PIs and other investigators as well as patient payments, which must comply with CMS (Center for Medicare and Medicaid Services) policy on ‘fair market value’ as well as the Federal ‘Anti-Kickback Statute’. The unit contains guidelines on clinical trial budgeting and subject payments. Finally, the chapter reviews IRB guidelines on advertising to recruit human participants for clinical trials, including stipulations against misleading and coercive language, as well as excessive incentives.

Chapter 34: Patient Recruitment, Retention and Compliance

The unit provides an overview of the process of patient (subject) recruitment in clinical trials, from population research to identify motives for participation, to media support for building up public awareness and interest, to community and physician outreach for referrals and enrollment. Additionally, the chapter identifies common barriers to meeting recruitment goals and outlines strategies for maximizing recruitment, such as relaxing overly stringent criteria, offering reasonable incentives such as travel reimbursement and highlighting benefits of participation. Similarly, the unit covers common causes of patient drop-out as well as strategies for minimizing drop-outs, such as improving patient experience (increased attention and listening to patients, flexible scheduling of visits to suit patients’ convenience and so on). Finally, the unit discusses novel strategies to increase patient retention and improve compliance in clinical trials; these techniques harness technology to yield better outcomes, for example, simplifying form completion through digitized forms with auto-fill features, gamifying elements of compliance reporting, and so forth.

Chapter 35: Misconduct and Fraud

This module discusses the various motives for committing scientific fraud and the fallout of fraudulent practices in clinical trials. A scale for classifying errors in clinical trial data is presented, with ‘honest, isolated mistake’ at one end of the spectrum and ‘deliberate data falsification with malicious intent’ at the other. Types of clinical data that may be falsified, methods used in falsification (fabrication, substitution, omission), as well as scenarios in clinical trials where falsification may be occurring are presented. Through this chapter, you will gain familiarity with the signs to watch out for during the actual clinical trials process. 

Chapter 36: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, including questions on all aspects of regulatory documents, site documents (TMF and contents), trial budgeting and payments, patient recruitment and scientific fraud.

Chapter 37: Site Visit Templates 

This module contains a set of templates that you can use for documenting the details of site monitoring as a CRA, either in their current form, or in a form adapted to the needs of your own study. The templates included in this unit include:

Site Qualification Visit (SQV) – checklist for preparations, questionnaire for assessing the site prior to the actual visit, assessment form and follow-up letter

Site Initiation Visit (SIV) – agenda for visit, confirmation letter to request PI attendance during SIV, report following SIV

Routine Monitoring Visit (RMV) – confirmation letter to request PI attendance, report following RMV, follow-up letter

Site Close-Out Visit (SCOV)  – confirmation letter to request PI attendance, agenda for SCOV, report following SCOV, follow-up letter

CRA transition letter  – document notifying site PI of appointment of new monitor (yourself as CRA) 

Chapter 38: Interviewing and Career

In this unit, you will find suggestions and recommendations for making a positive impact in interviews for CRA positions, as well as tips and strategies for making rapid progress in a clinical research career.

Chapter 39: Final Examination

This module comprises a comprehensive 51-item, self-paced quiz to assess your competency in the skills and knowledge required for a Clinical Research Associate position. 

https://www.beroeinc.com/category-intelligence/clinical-research-organizations-market/

https://www.linkedin.com/jobs/search?keywords=Clinical%20Research%20Associate&location=United%20States&geoId=103644278&trk=public_jobs_jobs-search-bar_search-submit&position=1&pageNum=0

https://www.centerwatch.com/articles/24791-demand-for-experienced-clinical-trial-professionals-outpacing-supply-acrp-says

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3317309/

https://www.niaid.nih.gov/research/dmid-investigational-product

https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research

Dixon JR. 1999. The international conference on harmonization good clinical practice guideline. Quality Assurance. 6(2): 65-74. DOI: 10.1080/105294199277860

https://www.fda.gov/files/drugs/published/E6%28R2%29-Good-Clinical-Practice--Integrated-Addendum-to-ICH-E6%28R1%29.pdf

https://www.who.int/groups/research-ethics-review-committee/recommended-format-for-a-research-protocol/

https://iaocr.com/finding-first-clinical-research-job/

https://jobs.newscientist.com/en-au/article/a-career-in-clinical-research/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/

St. Germain DC, Good MJ. 2017. Data management in clinical trials. In: Gallin JI, Ognibene FP, Lee Johnson L, editors. Principles and practice of clinical research. San Diego: Academic Press. p. 531-545. ISBN 978-0-12-849905-4

https://acrpnet.org/wp-content/uploads/dlm_uploads/2017/04/clinical-study-monitoring-competencies.pdf

https://www.clinicalleader.com/doc/starting-a-career-in-clinical-research-things-we-wish-we-knew-0001

https://www.proclinical.com/blogs/2021-9/how-to-get-a-job-as-a-clinical-research-associate-cra

https://acrpnet.org/2018/06/11/5-clinical-research-trends-emerge-at-acrp-2018/

https://www.collegechoice.net/sciences/clinical-research/best-masters-degrees/

https://acrpnet.org/certifications/cra-certification/

https://www.socra.org/certification/program-overview/

Pharmacovigilance: A Complete Guide to Pharmacovigilance and Drug Safety Training

The ultimate guide to clinical research monitoring.

CRA Careers at IQVIA

Help tackle healthcare’s greatest challenges to improve patient health.

Not ready to apply? Join our Global Talent Network .

Put your passion to work

IQVIA Clinical Research Associates play a vital role in the evolution of clinical development. They bring passion, ambition, and a deep level of expertise to help solve complex clinical issues while ensuring adherence to regulations and sponsor requirements. Here, you'll find the autonomy and flexibility you need to take your CRA career to the next level.

Choose your path

Sponsor-dedicated.

When you join as a sponsor-dedicated CRA, you’ll embrace the stability of a global contract research organization and harness the power of industry-leading technology. As part of this alignment, you'll gain valuable experience, working side by side one of our pharmaceutical customers, and expand your knowledge in a wide variety of therapeutic areas.

Our sponsor-dedicated model brings together the right people, experience and ideas to deliver high quality solutions specific to the customer’s needs.

Full-service

When you become a CRA as part of our full-service alignment, you'll embrace your passion for a specific therapeutic area and support a variety of sponsors. With access to world-class training and cutting-edge technology, developed specifically for IQVIA CRAs, you'll have the resources you need to create the career you want.

Our full-service model delivers cutting-edge clinical research through state-of-the-art innovation.

IQVIA Biotech

When you pursue a CRA career with IQVIA Biotech, you'll work directly with customers in a collaborative environment to help change the face of biotech. Using your extensive therapeutic knowledge, you’ll oversee uniquely-focused clinical studies, where you’ll be exposed to pioneering protocols and experience a dedicated partnership with your team like none other.

IQVIA Biotech is at the forefront of clinical trials in a variety of therapeutic areas through the delivery of flexible solutions within the biotech sector.

IQVIA empowers you to drive your own path within the organization. As no person's route is the same and the clinical research landscape is forever changing, you are encouraged to continually seek career growth opportunities and align your interests with your career goals.

Senior Clinical Research Associate 2

At IQVIA, we are committed to supplying our CRAs with the right tools, training and development support to allow for success and career growth. In addition to the rewarding work, collaboration and engaged line management, there is a constant focus on development as your career growth supports also the growth of the company.

Director, Clinical Operations

For me, it’s the people and knowing I’m making a difference in creating a healthier world that inspire me to come to work every day. I can go to anyone with a challenge, and they are willing to help. Together, we’re thinking outside of the box to navigate each sites’ unique needs and challenges.

Senior Clinical Research Associate

Explore unlimited opportunities

Clinical Research Associates can leverage their experience in a variety of ways that enable them to pursue their unique passions. Whether you choose to advance within a specific therapeutic area or want to explore something new, you can create the career you want. Explore the various career opportunities when you join IQVIA as a CRA.

What you can expect

All CRAs at IQVIA, regardless of alignment, thrive within our dynamic culture and experience:

Professional Development

Work-Life Balance

Supportive Leadership

Best-in-Class Training

Collaboration

Explore clinical monitoring jobs.

• R1388555 Senior Clinical Research Associate Learn more Multiple Locations
• R1410725 Senior Clinical Research Associate (Local PM hybrid) Learn more Multiple Locations
• R1405173 Clinical Research Associate - Sponsor Dedicated Learn more Multiple Locations

Join our Global Talent Network

Let’s stay connected. Sign up to receive alerts when new opportunities become available that match your career ambitions.

Job Category Select a Job Category Administrative Support Advanced Analytics Business Systems Analysis Client Services Clinical Data Management Clinical Operations Clinical Project Management/Leadership Clinical Trial Supply & Logistics Connected Devices Consulting Contract Management Database Management Systems Finance Human Resources Information Security Internships IT Design & Development IT Infrastructure IT Support Lab Science Lab Science Advisors Lab Services Laboratory Laboratory Projects Legal and Regulatory Lifecycle Safety Marketing Medical Medical Affairs Medical Communications Medical Sales & Services Monitoring Patient Centric Services (PCS) Phase 1/Clinic Operations Product Support (Tier 3) Production Project and Program Management QA & Testing Quality Assurance Sales Sales Support Software Development Engineering Statistician Strategic Supplier Services Strategy and Corporate Development Technical Writing

Remote Select... Yes

Areas of Interest

Confirm Email

Search for a location and select one from the list of suggestions. Select a job category from the list of options. Finally, click “Add” to create your job alert. Multiple job alerts may be created by repeating these steps.

Explore life at IQVIA

Clinical Research Associate (II or Senior) - Germany

• Location: Germany
• Categories Clinical Monitoring
• __vacancyopjusttionswidget.opt-Business Area__ ICON Strategic Solutions
• __vacancyopjusttionswidget.opt-Remote Working __ Remote

TA Business Partner

• Icon Strategic Solutions

Send me a message

About the role, this vacancy has now expired. please see similar roles below....

The Clinical Research Associate will perform site activities for Phase I-IV studies operating as the main point of contact for the site during a study. Drive and execute monitoring plans, ensure site GCP compliance, write trip reports, resolve issues and facilitate open issue resolution, work on recruitment strategies, and monitor safety at the site.  The CRA  will conduct site qualification visits as assigned, site initiation visits and site training, routine monitoring visits, and site close-out visits. Perform investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs).

What you will be doing,  Including but not limited to:

• Adhere with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner
• Knowledge of applicable SOPs, guidelines and study procedures
• Conduct study start-up activities related to in-house monitoring activities
• Assist with protocol and CRF review
• Complete study feasibility and site selection activities
• Conduct telephone screening interviews, administer site questionnaires, collect and review regulatory documents, assist with investigator grants negotiation
• Assist with investigator meeting activities including organization, preparation, and attendance
• Provide status of site activity to Project Manager
• Perform site management activities including but not limited to site qualification visit, site initiation visits, site training, site routine monitoring visit, and site close out visits
• Establish and maintain good rapport with study sites;a.maintain frequent telephone communication with sites, providing guidance to study coordinators and investigators as necessary and in agreement per monitoring plan
• Write study visit reports and follow up letters within the timeline established by the applicable SOPs and guidelines
• Coordinate timely shipment of clinical supplies and study drug to sites in collaboration with regional CRAs
• Maintain adequate site tracking records
• Follow up of drug safety issues and safety reports in timely manner
• Communicate site study issues, concerns, and progress to Sr.CRA , Lead CRA, Project Manager and Clinical Operations Manager accordingly
• Assist with the implementation of corrective actions when appropriate
• Conduct in-house review of Case Report Forms
• Assist with data query resolution
• Perform telephone monitoring activities in order to obtain study status information
• Prepare/review all patient tracking records
• Input and maintain study information in tracking systems
• Provide information concerning subject status for financial reimbursement to sites
• Conduct and assist with administrative activities as a member of the project team;attend staff/project team meetings as required, document all investigator information and study contacts, assist with execution of investigator agreements and grant negotiations, prepare reports as defined by SOPs
• Ensure adherence to cost effective travel.

#LI-Remote:

Education and Work Experience:

• At least 1.5 years as an independent CRA, including conducting monitoring visits for clinical trials, from either a pharmaceutical company or a CRO environment.
• A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
• You will be educated to degree level in a life science discipline or be a licensed healthcare professional.
• Fluency in German and English is essential
• Scientific degree (BSc, MSc or PhD), have equivalent experience or be a licensed healthcare professiona

Knowledge, Skills, and Abilities:

• Excellent verbal and written communication skills
• Good verbal and written English
• Strong computer literacy e.g. MS Word, Excel and PowerPoint
• Excellent organizational, record retention, and time management skills
• Excellent decision making skills
• Excellent customer service and interpersonal skills
• Knowledge of ICH-GCP, FDA & local regulatory requirements
• Ability to manage the sites independently.

Why ICON? Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development. ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

ICON and you

ICON history

Career Pathways

Benefits & Rewards

Environmental, Social & Governance

Women in IT

Application process

Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.

Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.

One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.

Day in the life

Teaser label

Content type

Publish date

To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her

Brazil-based CRA II Debora Oh shares her tips on how to become a great CRA and provides insight into life at ICON.

How to progress as a Clinical Research AssociateTo thrive as a Clinical Research Associate (CRA), it is imperative to cultivate a multifaceted skill set and demonstrate unwavering commitment to exce

 Senior CRA Yemi Moses recounts her development and shares her career ambitions with ICON plc.

Senior Clinical Research Associate Suzaita Hipolito talks about the satisfaction gained from working in Clinical Research. “What would it look like to wake up every day feeling happy and fulfilled?

Senior Clinical Research Associate, Suzaita Hipolito, talks about how working in Clinical Research gives her happiness and fulfilment.

Suzaita Hipolito

Press play to find out more

Similar jobs at ICON

Clinical Monitoring

Remote Working

Office Based

Business Area

ICON Strategic Solutions

Job Categories

Description

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech

2024-109835

Expiry date

CRA II / Senior CRALocation: Melbourne, Sydney, Perth As a Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthca

2024-109410

As Clinical Research Associate (CRA), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.  A CRA is a professional who cont

2023-103904

Senior CRALocation: Sydney, Australia ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourc

2024-109131

2023-104179

As a Senior Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be partnering with one

2023-103968

Browse popular job categories below or search all jobs above