Shop Our Courses Starting at $29.00 | Our limited offer!
Access to all Academy Services
Modules including:
- e-learnings
- assignments
- knowledge checks
Industry recognized Professional Certification
- Get Cognitio Certificate
- GCP Certification
5 Steps Guide to Get Your Dream Job
- Set clear goals
- Get properly trained
- CV, CV, CV
- Ace Your Interview
- Negotiate
Global Clinical Research Jobs
- Weekly new Global Jobs
- Skip the Application Line
- Join Career Events
Medicines Development Process, Good Clinical Practice
- Background of medicines development
- Research and discovery stage & product development
- Clinical development
- Regulatory submission, Health Technology Assessment, lifecycle management
- ICH GCP and other applicable regulations
Regulatory Environment in the USA
- Applicable international and national regulations
- ICH GCP E6 (R2)
- FDA Regulation
- Quality Assurance: Audits and Inspections
Clinical Trial Design & Clinical Research Roles and Responsibilities
- The Study Protocol
- Elements of a Study Protocol according to ICH GCP
- Trial Design
- Methodologies
- Roles and Responsibilities
- Ethics Committees
- Sponsor / Monitor
- Investigator
- Competent Authority
The Role of the Clinical Trial Assistant
- The CTA as member of the clinical study team
- Typical activities of the CTA related to:
- Managing Essential Documents
- Handling Investigational Medicinal Product
- Supporting Data Management
- Interaction with Ethics Committees and Regulatory Bodies
Our Expert Instructors
Vince W
CRA Instructor
Cynthia L
CRA Instructor
Jessie C
CRA Instructor
Lauren M
CRA Instructor
Other Clinical Research Courses
Ready To Get Started?
Get the knowledge and resources you need to land your dream job in clinical research.