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Regional Clinical Research Associate · Boston, MA
Senior Clinical Research Associate Responsibilities include:
- Monitor assigned investigative sites ·
- Conduct pre-study, initiation, interim monitoring and close-out visits ·
- Train assigned investigative sites in GCP and ensure these sites are conducting research according to protocol and Federal (GCP) regulations ·
- Review investigative sites’ regulatory documentation and ensure compliance with GCP ·
- Monitor informed consent process ·
- Serve as main point of contact with assigned investigative sites ·
- Review and update clinical files at the assigned investigative sites ·
- Initiate actions to ensure all assigned investigative sites are in compliance with protocol and GCP ·
- Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a valid representation of what happened to a subject while participating in the study ·
- Create and properly file trip reports, follow-up letters and telephone contacts for assigned investigative sites
- Evaluate and Resolve Data Queries ·
- Evaluate study query trends and interact with Study Team in improving data quality ·
- Assist investigative sites with timely and accurate resolution of...
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