Research Regulatory Specialist

Position Title:

Department:

Job Description:

The Research Regulatory Specialist is responsible for ensuring compliance with federal, state, and institutional regulations governing human subject research. This position will support research teams by overseeing regulatory submissions, maintaining compliance documentation, and ensuring adherence to ethical research practices. The role involves coordinating with investigators, Institutional Review Boards (IRBs), and regulatory agencies to facilitate research approvals and ongoing compliance.

Essential Responsibilities

Responsibilities listed in this section are core to the position. Inability to perform these responsibilities, with or without accommodations, may result in disqualification from the position.

• Prepare, submit, and track regulatory documents, including IRB applications, amendments, and continuing review reports
• Ensure compliance with federal regulations (e.g., FDA, OHRP), institutional policies, and ethical guidelines
• Serve as a regulatory liaison between investigators, study teams, IRBs, and other regulatory bodies
• Maintain organized and accurate regulatory documentation, including consent forms, training records, and correspondence
• Provide guidance to investigators and study staff regarding regulatory requirements and best practices
• Monitor research activities for compliance and assist in audits or inspections as needed
• Develop and conduct training sessions on regulatory compliance and research ethics
• Stay informed on regulatory changes and advise research teams accordingly

General Responsibilities

• Performs other duties as assigned.

Minimum Requirements

Education: Bachelor's Degree required.

Experience: At least 3 years of experience in clinical research required.

License/Certification/Registration Requirements: Certified IRB Professional (CIP) issued by PRIM&R or Certified Clinical Research Professional (CCRP) issued by SOCRA preferred.

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OU Health is an equal opportunity employer. We offer a comprehensive benefits package, including PTO, 401(k), medical and dental plans, and many more. We know that a total benefits and compensation package, designed to meet your specific needs both inside and outside of the work environment, create peace of mind for you and your family.