Regulatory Compliance Administrator

Regulatory Compliance Administrator

Apply for the Regulatory Compliance Administrator role at University of Chicago
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Base pay range: $65,000.00/yr - $90,000.00/yr

BSD OCR - Regulatory Compliance

The Human Research Protections Program (HRPP) in the Biological Sciences Division has responsibilities including establishing, communicating, and implementing policies for oversight of human subjects research. It provides administrative support for internal IRBs, continuing education for IRB members, training requirements for divisional faculty and staff, compliance oversight for exempt or non‑human subjects research, review of protocols relying on external IRBs, and review of protocols reviewed by internal IRBs.

Federal regulations require the institution to maintain adequate documentation of IRB activities, identify and appoint IRB members, maintain records, consider institutional reliance, and other duties. The HRPP works with University Research Administration and the Institutional Official, reporting to the Vice Dean of Clinical Sciences Research.

The Regulatory Compliance Administrator (RCA) maintains regulatory compliance programs, interprets systems to identify risk areas, and coordinates internal audits. With moderate direction, the RCA participates in compliance documentation, training, and committee formation. The RCA is a member of the Institutional Review Board Staff, supporting IRBs in the Division of Biological Sciences and the University of Chicago Medical Center. The RCA reviews human subject research protocols to ensure compliance with international, federal, state, and local rules and ethical principles regarding the use of human subjects and radioactive materials.

The RCA handles all aspects of committee management, functions, and development, reviewing approximately 3,500 new and continuing projects each year, and works on special projects as assigned.

• Advise investigators on protocol preparation, interpretation of federal, state, and local regulations, and implementation of institutional or HRPP/IRB policies.
• Review submitted protocols to identify and resolve problems before IRB review, ensuring integrity and determining scope and review requirements.
• Prepare comments for investigators on submissions, respond to inquiries about IRB or RADRAC policies/procedures, report requests, or renewal information.
• Compose summaries (federally mandated minutes) of IRB committee deliberations and outcome letters to disseminate decisions and follow‑up activities.
• Participate in planning and execution of training programs, prepare training and informational materials, including updates to the IRB website, and develop communications with faculty and administrators.
• Prepare, complete, and submit all compliance documentation on a routine basis; coordinate compliance committee meetings.
• Coordinate department or clinic compliance with moderate guidance.
• Plan and execute internal and external audits and activities to support regulatory agency inspections.
• Perform other related work as needed.

Minimum Qualifications: A college or university degree in a related field.

Experience: 2‑5 years of experience in a related discipline, with knowledge and skills developed in this area.

Preferred

Competencies:

• Ability to work independently with high initiative, problem‑solving, and decision‑making.
• Ability to work as part of a team.
• Ability to maintain confidentiality.
• Ability to manage multiple projects simultaneously, set priorities, and meet deadlines.
• Strong organizational and project‑management skills.
• Expertise in Microsoft Word and Excel.
• Excellent written and verbal communication skills.
• Analytical skills.
• Ability to manage stressful situations.

Office setting.

• Resume (required)
• Cover Letter (required)

Documents must be uploaded via the My Experience page, in the section titled Application Documents of the application.

Benefits eligible:
Yes. The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off.…