The Regulatory Coordinator III will provide supervision of other regulatory staff. Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC. 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 insure all regulatory documents and requirements are met and up-to-date. May plan and coordinate strategies for improving efficiency, action plans to improve quality, or training and education of personnel. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB)

Primary Duties and Responsibilities

• Provides supervision of other regulatory staff.
• 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.
• 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.
• May participate in internal auditing of regulatory documents.
• May supervise Regulatory Coordinator I/II and/or provide training and education of other personnel.
• May participate in centralized activities of the department 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)
• and local Institutional Review Board. Primary Duties and Responsibilities
• 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.
   

• BA/BS Degree required
• Minimum of five (5) years of directly related experience in regulatory affairs, clinical research, or a similar field, demonstrating expertise in compliance, protocol management, and regulatory submissions
• Leadership Experience: Minimum of 3 years leading a team, preferably with more than 5 staff.
• Regulatory Experience: Minimum of 5 years managing 30+ studies, ideally within a Cancer Center setting.
• Licenses: Specialty research certification preferred.

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