Regulatory Coordinator III - Hybrid

Primary Duties And Responsibilities

• Oversees daily activities and provides supervision of regulatory staff, including Regulatory Coordinator I and II and assists with coverage as needed.
• Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC.
• Sets and maintains research files and documentation pertaining to regulatory requirements for clinical trials.
• Meets with monitors from sponsors and represents the Cancer 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 research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
• May participate in internal auditing of regulatory documents.
• May participate in required training and education programs and may provide training and education of other personnel.
• May participate in centralized activities of the department and/or institution.
• May plan and coordinate strategies to improve existing standard operating procedures related to regulatory affairs.
• May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA), Institutional Review Board(s), Good Clinical Practices (GCP) and HIPAA standards.

Qualifications

• BA/BS degree required.
• Minimum of five (5) years of directly related regulatory experience supporting clinical research studies.