Course Description
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.
Who is the target audience?
• Clinical research associate
• 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
What am I going to get from this course?
1. Describe the drug development process, the importance of Good Clinical Practice (GCP), and the roles and responsibilities of the research team
2. Describe a CRA management philosophy based on competencies, performance objectives and metrics based on effective communication skills
3. Define the IRB/IEC regulations and describe the elements of a protocol and amendments
4. Outline required elements of the informed consent
5. Describe the processes of clinical trial management
6. Describe methods for managing clinical research projects more effectively
7. Define the impact of quality assurance and audits in clinical research
