- Ensure patient safety and data integrity at clinical research sites through regular quality assurance reviews.
- Conduct comprehensive reviews of study-specific regulatory binders and clinical documents to verify compliance with GCP standards.
- Execute the yearly corporate audit plan, track quality audits, and prepare outcome reports for management.
- Partner with research staff and PIs to resolve compliance issues and develop, track, and monitor CAPA plans.
- Coordinate and provide support for on-site audits and inspections conducted by external providers and regulatory agencies.
- Maintain internal quality systems, compliance trackers, and operational programs.
- Draft and maintain quality assurance Standard Operating Procedures (SOPs) to align with evolving regulations.
GCPQuality Assurance