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Senior Clinical Research Regulatory Coordinator, Center for Clinical Investigation
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Full-time
- The Center for Clinical Investigation (CCI) provide research support for the BWH investigator community.
- The CCI is designed to provide infrastructure support to the investigative community, leading to a more effective and robust clinical research enterprise at Brigham and Women’s Hospital.
- The Senior Research Regulatory Coordinator (RC) works under the direction of the CCI Executive Director, Research Operations Director and Principal Investigator(s) to complete the regulatory requirements of clinical research projects.
- Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, Industry Sponsors, and third-party auditors.
- Performs preparatory regulatory compliance audits of IRB-approved clinical research protocols at MGB institutions to ensure compliance with FDA, OHRP and other state and government regulations, Good Clinical Practice guidelines (GCP), as well as with MGB clinical research policies.
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