Lead Regulatory Compliance Officer | CCC - Clinical Trials Office

Position Summary

Lead Regulatory Compliance Officer serves as primary resource in regulatory aspects by providing regulatory expertise to assure research protocols are in compliance with university, state and federal regulations across research groups managed by the OSUCCC Clinical Trials Office.

Responsibilities

• Assists the Regulatory Manager with the daily oversight of the Regulatory team and monitoring of the regulatory research compliance function across all disease teams managed by the Clinical Trials Office (CTO).
• Conducts interviews for regulatory staff and trains, mentors, and supervises staff. Serves as the subject matter expert for all regulatory compliance officers within the department by monitoring & ensuring compliance with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state & industry sponsor regulations.
• Answers questions and provides technical support to junior members on the team.
• Provides coverage/back up as needed for Regulatory manager and/or team members. Serves as lead Regulatory contact for external audits; performs quarterly spot checks of regulatory files.
• Participates in the development of SOPs and Processes for the regulatory team to stay current with the changing regulatory requirements and training. Participates in the creation and delivery of onboarding and educational training programs, tools and materials for CTO staff, and investigators.
• Provides regulatory guidance, direction and support to all members of research team.
• Stays current on legislation, rules, regulations, procedures, and development; educate physicians and staff regarding change as related to clinical research protocols, university staff, affiliates, and patients.
• Work with CTO Managers and coordinators as needed to ensure understanding of study protocols.

Job Requirements

Bachelors Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required; Masters degree in a relevant field desired; clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) required.

Three to five years of experience in a clinical research or administrative capacity working on clinical research projects required; knowledge of clinical research regulations and compliance issues especially related to the use of human and animal subjects required; experience and knowledge of federal & industry research sponsor requirements preferred; experience in a regulatory affairs capacity in a medical research setting desired; experience in protocol development desired.

Research Administration / Research Compliance - Individual Contributor - Specialized - S4 Consultant