Clinical Trial Coordination
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Table of Contents
Table of Contents
This course provides educational information and does not replace professional medical advice, diagnosis, treatment, or clinical judgment.
Build the organizational and regulatory knowledge base that clinical trial coordinators use daily to keep multi-site research studies compliant, on schedule, and centered on participant safety.
What You Will Learn
- 1 Learn the foundational structure of clinical trials, including phases, sponsors, and regulatory bodies governing research conduct
- 2 Understand the roles and responsibilities of a clinical trial coordinator within the broader research team
- 3 Apply informed consent principles and participant recruitment strategies within ethical and regulatory boundaries
- 4 Analyze protocol documents and case report forms to support accurate data collection workflows
- 5 Develop skills in regulatory submission tracking, including IRB and ethics committee correspondence
- 6 Explore site management practices, including monitoring visits, audits, and sponsor communication
- 7 Build proficiency in participant safety monitoring, adverse event reporting, and pharmacovigilance basics
- 8 Implement data management and quality assurance practices for clinical trial documentation
- 9 Learn budget tracking, vendor coordination, and study supply management fundamentals
- 10 Create a comprehensive study close-out and archiving process aligned with regulatory retention standards
What's Included
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Clinical Trial Coordination