Careers in Food and Drug Law
Regulatory Coordinator I
Cedars-Sinai
| Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC. Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies. Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study. Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies. Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials. Meets with monitors from pharmaceutical companies and represents the Medical Center during these meetings. Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date. Attends weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs. #LI-Academic
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