Sale!

Clinical Research Coordinator Course

1,000.00 800.00

Education program for health-care professionals who works under the direct supervision by PI or/and Sponsor/CRO for the purpose of conducting Clinical Trials. Education is intended for doctors, pharmacists, dentists or persons who have graduated from colleges of some related sciences.

What Will I Learn?

  • Supporting investigators with patient recruitment
  • Administrative coordination of ethics committee submissions to hospitals
  • Support of the CRA during monitoring visits
  • Maintenance of the Investigator’s file
  • Coordination of patient visit schedules
  • Drug accountability and dispensing logs
  • Coordination of sample shipments
  • Payment of patient expenses
  • Supporting data entry/query resolution/SAE notification
Topics for this course

37 Lessons

Introduction Video
Introduction / CRC in Clinical Trials  3:13

Module 1: Introduction to Clinical Trials
History of Pharmacology  16:16
Overview of drug development process  31:06
Design and Types of studies  24:25

Module 2: Study design
General Considerations for clinical trials  1:05:21
GCP Wheel  1:14:26
Helsinki Declaration, Belmont Report  18:27

Module 3: Roles and Responsibilities
Ethics Committees  14:13
Sponsor’s Responsibilities  17:01
Principal Investigator’s Responsibilities  7:41
Clinical Research Associate – roles and responsibilities  4:47
ICH-GCP: Good Clinical Practice for Study Nurses and Study Coordinators  16:17
Soft Skills 1 – Communication skills  17:56
Soft Skills 2 – Time management  15:48

Module 4: Regulatory
The European Union Clinical Trail Directive  14:29
Clinical Trial Regulation EU No 536/2014  14:15
Final Guidance on Statement of investigator – form FDA 1572  14:40
Compensation in Clinical Trials  7:33
Data Protection  16:53
Informed Consent Form  12:48

Module 5: Essential Documents
Protocol  10:10
Essential Documents  16:29
Trial Master File  10:27
Green Light Package: Documentation for Investigational Drug Release  11:34
Source Documents in Clinical Trials  11:22
Source Document Verification  15:05

Module 6: Patient Documentation in CRF
Clinical Report Form  5:42
Electronic Data Capture Systems – EDC  7:53
Electronic Patient-Reported Outcome (PRO) systems – ePRO  8:04

Module 7: Safety Reporting
Pharmacovigilance in Clinical Trials – Concept and Definitions  22:25
Serious Adverse Events (SAE) Reporting  21:14

Module 8: Clinical Trial Management
Patient Recruitment  10:56
Drug Accountability  8:10
Fraud and Misconduct/Audit and Inspection  57:32
Site Management Organization  3:41

Summary video
Summary  1:50

Final Exam

Feedback

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