The Regulatory Coordinator I prepares and submits protocols and supporting documents to regulatory bodies. This role submits continuations, amendments, responds to questions, generates reports, and maintains files research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing the Medical Center when meeting with pharmaceutical companies, attending weekly team meetings, and working with other staff to ensure all regulatory documents and requirements are met and up-to-date. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
- Prepares and submits protocols and supporting documents to regulatory bodies.
- Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies.
- Responds to all questions from the IRB 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.
EDUCATION AND EXPERIENCE REQUIREMENTS:
Certification/License: Specialty research certification preferred. Experience:
2-3 years directly related experience