The Clinical Research Site Manager oversees the daily operations of a clinical research site to ensure that clinical trials are conducted efficiently, ethically, and in compliance with all applicable regulations and protocols. This role involves managing site staff, coordinating with sponsors, and maintaining study timelines and quality standards.
Key Responsibilities:
- Manage all aspects of clinical trial operations at the site level
- Ensure compliance with study protocols, GCP, ICH, FDA regulations, and institutional policies
- Supervise and support clinical research staff, including coordinators and assistants
- Act as a liaison between site staff, sponsors, CROs, and monitors
- Oversee patient recruitment, enrollment, and retention efforts
- Maintain accurate and timely study documentation and data entry
- Prepare for and participate in monitoring visits, audits, and inspections
- Monitor site performance metrics and address issues as needed