Regulatory Compliance Administrator

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$65,000.00/yr - $90,000.00/yr

BSD OCR - Regulatory Compliance

The responsibilities of the Human Research Protections Program (HRPP) in the Biological Sciences Division include:

• establish, communicate, and implement policies for the oversight of human subjects research for issues both within and outside of the purview of the internal IRBs
• provide administrative support for the internal IRBs
• provide continuing education to IRB members
• human subjects research training requirements for divisional faculty and staff
• compliance of exempt or non-human subjects research with institutional and local policies
• review of protocols that rely upon an external IRB
• review of protocols reviewed by internal IRBs

Federal regulations outline the responsibilities of the Institution, including maintaining adequate documentation of IRB activities, identification and appointment of IRB members, maintenance of all records relating to research, institutional reliance considerations, and other responsibilities. The HRPP assumes these responsibilities in conjunction with University Research Administration and the Institutional Official. The HRPP and IRB administrative offices report up to the Vice Dean of Clinical Sciences Research.

The Regulatory Compliance Administrator (RCA) maintains regulatory compliance programs, interprets system issues to identify areas of risk, and coordinates internal audits. With a moderate level of direction, the RCA participates in compliance documentation, training, and committee formation. The RCA reviews human subject research protocols to ensure compliance with international, federal, state, and local rules and regulations and ethical principles regarding the use of human subjects in research and the use of radioisotopes and radioactive drugs in humans.

The RCA handles all aspects of committee management, function and development, including the review of approximately 3,500 new and continuing projects each year and will work on other special projects as assigned.

• The RCA will advise investigators regarding the preparation of protocols, the interpretation of federal, state, and local regulations, and the implementation of institutional or HRPP/IRB policies.
• The RCA will review each submitted protocol to identify and resolve problems prior to IRB review and ensure the integrity of information, including making the initial determination as to the scope of the protocol and therefore its review requirements.
• The RCA will prepare comments for investigators concerning submissions and respond to researcher inquiries regarding IRB or RADRAC policies/procedures, requests for reports, or renewal information.
• The RCA will compose summaries (federally‑mandated minutes) of the IRB Committees' technical deliberations and outcome letters for dissemination to research teams which highlight Committee concerns, decisions and need for follow‑up activity.
• The RCA will participate in the planning and execution of training programs, in the preparation of training and informational materials, including the IRB Website, and development of communications with faculty and administrators.
• Prepares, completes and submits all compliance documentation on a routine basis. Coordinates compliance committee meetings.
• Coordinates department or clinic compliance with moderate level of guidance.
• Plans and executes internal and external audits and activities to support regulatory agency inspections.
• Performs other related work as needed.

College or university degree in a related field.

2–5 years of work experience in a related job discipline.

• Ability to work independently with a high degree of initiative, including problem‑solving and decision‑making.
• Ability to work as part of a team.
• Ability to maintain confidentiality.
• Ability to work on multiple projects simultaneously, set priorities, and meet deadlines.
• Strong organizational and project‑management skills.
• Exper…