Regulatory Coordinator Assistant

Prepare, compile, and submit regulatory documents including study feasibility questionnaires, Investigator Brochures, Protocol Amendments, and SAE Reports to sponsors, IRBs, and other regulatory bodies. Address inquiries from clinical trial teams, sponsors, and regulatory bodies while generating detailed reports and maintaining electronic and paper documentation for clinical trials. Schedule and coordinate site initiation, interim monitoring, and close-out visits, ensuring compliance with FDA, ICH-GCP, and local regulations. Collect and track regulatory logs, licenses, and manuals, periodically review source documents and case report forms for accuracy, and participate in clinical trial meetings and training sessions. Maintain archiving and retention of regulatory documentation in a traditional outpatient clinic or office environment Monday through Friday.