Regulatory Compliance Administrator

Department

BSD OCR - Regulatory Compliance

About the Department

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.

Job Summary

The job maintains regulatory compliance programs, including the interpretation of systems to identify areas of risk and may coordinate internal audits. With a moderate level of direction, participates in compliance documentation, compliance training, and compliance committee formation.

The Regulatory Compliance Administrator (RCA) is a member of the Institutional Review Board Staff. The RCA team provides administrative support to the Institutional Review Boards 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 regulations and ethical principles regarding 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 responsibility for the review of approximately 3,500 new and continuing projects each year and will work on other special projects as assigned.

Responsibilities

• 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.

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

Work Experience:

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Certifications:

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Preferred Qualifications

Education:

• College or university degree in related field.

Experience:

• Knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Preferred Competencies

• 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.

• Expertise in Microsoft Word, Excel.

• Excellent written and verbal communication skills.

• Analytical skills.

• Ability to manage stressful situations.

Working Conditions

• Office setting.

Application Documents

• Resume (required)

• Cover Letter (required)

Job Family

Legal & Regulatory Affairs

Role Impact

Individual Contributor

Scheduled Weekly Hours

40

Drug Test Required

No

Health Screen Required

No

Motor Vehicle Record Inquiry Required

No

Pay Rate Type

Salary

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FLSA Status

Exempt

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Pay Range

$65,000.00 - $90,000.00

The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.

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. Information about the benefit offerings can be found in the Benefits Guidebook.

Posting Statement

The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

 

Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.

 

All offers of employment are contingent upon a background check that includes a review of conviction history.  A conviction does not automatically preclude University employment.  Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.

 

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