Found Description
Overview
We are seeking qualified candidates for anticipated Clinical Operations Lead needs (COL and Sr. COL) to support our Clinical Monitoring team.
Responsibilities
- Provide overall oversight of regional CRAs to ensure site compliance with study protocols, ICH-GCP, local regulations, and project timelines.
- Lead and support monitoring activities, including co-monitoring visits and quality review of monitoring reports.
- Actively manage site, country, and regional performance (startup, recruitment, data quality, TMF, and timelines), escalating risks and issues as needed.
- Serve as the primary operational liaison between CRAs, project teams, and sponsors, delivering regular status updates and guidance.
- Train, mentor, and support CRAs on study-specific procedures, expectations, and performance standards.
- Oversee study startup, feasibility, and site management activities, including temporary direct site...
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