Clinical Research Associate (CRA) Course

1,500.00€

The CRA plays an important role  in  clinical  research  especially  in  monitoring  the  processes  of  clinical  trials.  This course provides practical training related to CRA job function and covers all the activities to promote successful monitoring studies for investigational products whether drug, biologic, and device trials. The course also describes the basics of project management adapted to clinical trials and emphasizes on an overview of pharmacovigilance through a good understanding of the current principles and guidelines. Upon course completion, participants will be provided training certificates.

What Will I Learn?

  • Course describes the drug development process, the importance of Good Clinical Practice (GCP), and the roles and responsibilities of the research team
  • Describes a CRA management philosophy based on competencies, performance objectives and metrics based on effective communication skills
  • Course defines the IRB/IEC regulations and describe the elements of a protocol and amendments
  • Course outline required elements of the informed consent
  • Describes the processes of clinical trial management
  • Describes methods for managing clinical research projects more effectively
  • Defines the impact of quality assurance and audits in clinical research
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Topics for this course

42 Lessons

Introduction Video
Introduction / Clinical Research Associate online training course  3:15

Module 1: Drug Development Process & GCP guideline
History of Pharmacology  16:16
Drug development and Clinical Pharmacology  11:03
General Considerations for clinical trials  1:05:21
Design and types of clinical trials  24:25
Overview of The Drug Development Process  31:06
GCP Wheel  1:14:26
Ethics Committees  14:13
Sponsor’s Responsibilities  17:01
Principle Investigator’s Responsibilities  7:41
The European Union Clinical Trial Directive  14:29
Clinical Trial Regulation EU No 536/2014  14:15
Final Guidance on Statement of investigator – form FDA 1572  14:40

Module 2: Principles of Clinical Research Associate
The role of Clinical Research Associate  12:00
Soft Skills 1 – Communication skills  17:56
Soft Skills 2 – Time management  15:48

Module 3: Study Documentation
Informed Consent Form  12:48
Protocol  10:10

Module 4: Clinical Trial Management
Monitoring and Source documents  16:23
Feasibility Process and Site Evaluation Visits  37:42
Site Evaluation Visit  20:40
Site Evaluation Visit Report  23:54
Investigators Meeting and CRA Training  14:47
Clinical study Initiation and Monitoring  57:04
Close Out of the clinical trial  28:26
Fraud Misconduct/Audit and Inspection  57:32
Drug Accountability  8:10

Practice Quiz

Module 5: Project management
Project Team  17:47
Project Management 1 – Role and expectations  49:34
Project Management 2 – Monitoring guidelines  34:51

Module 6: Biostatistics
Medical Statistics 1  33:27
Medical Statistics 2  11:55
Medical Statistics 3  22:55

Module 7: Data Management
Green Light Package: Documentation for Investigational Drug Release  11:34
Source document verification  15:05
Essential documents  16:29
Trial Master File  10:27
Pharmacovigilance in Clinical Trials – Concept and Definitions  22:25
Serious Adverse Events (SAE) Reporting  21:14
Safety Reporting  6:38

Course Summary
Summary  1:29

Final Exam

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Target Audience

  • Clinical research associates
  • Experienced Clinical Trial Assistants or Clinical Trial Coordinators
  • Any employee working in related area and seeking for new role and skills (Nurse, Pharmacist, Students from Science or Public Health Background)
  • Pharmaceutical Industry Employees
  • Medical Doctors involved in Clinical Research
  • PV Specialists

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