The Clinical Research Site Manager is responsible for managing the day-to-day operations of a clinical trial site to ensure high-quality, compliant, and efficient execution of clinical studies. This role oversees site staff, coordinates with sponsors and CROs, ensures regulatory compliance, and supports patient recruitment and retention activities.
Key Responsibilities:
- Manage site operations to ensure studies are conducted in compliance with protocols, GCP, and regulatory requirements
- Supervise and support site personnel (e.g., study coordinators, nurses, and support staff)
- Maintain essential regulatory documents and site files (ISF)
- Act as primary liaison with sponsors, CROs, and monitors
- Oversee and support patient recruitment, enrollment, and retention efforts
- Ensure accurate and timely data entry and query resolution in EDC systems
- Prepare for and support monitoring visits, audits, and inspections
- Track study budgets, assist with contract execution, and manage site-related finances