NoyMed Academy Certified Clinical Research Associate
Monitor clinical trial sites for data quality, safety, and GCP compliance.
About this program
Prepares new and transitioning monitors to run site visits, verify source data, manage findings, and keep studies inspection-ready.
Who it is for
Life-science graduates, study coordinators, and nurses moving into monitoring roles.
Prerequisites
- Life-sciences background or clinical site experience
- Familiarity with ICH-GCP (helpful, not required)
- Willingness to travel (role-dependent)
Curriculum outline
1. ICH-GCP and the regulatory landscape
The rules that govern trial conduct.
Topics: ICH E6(R2) · Roles and responsibilities · Essential documents · Informed consent
2. Site selection and initiation
Getting a site ready to enroll patients.
Topics: Feasibility · Qualification visits · Site initiation · Training and delegation
3. Monitoring visits
On-site and remote monitoring practice.
Topics: Source data verification · Risk-based monitoring · Visit reports · Follow-up letters
4. Safety and issue management
Handling AEs, deviations, and CAPAs.
Topics: AE/SAE reporting · Protocol deviations · Root cause and CAPA · Escalation
5. Close-out and inspection readiness
Ending a study cleanly.
Topics: Close-out visits · TMF completeness · Audit and inspection support
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