Regulatory Compliance Administrator

Department

BSD OCR - Regulatory Compliance

About the Department

The Office of Clinical Research (OCR) is dedicated to supporting the infrastructure for the management and administration of clinical research at The University of Chicago as well as individual research programs with the goal of improving communication, consistency, and collaboration across the Biological Sciences Division and UChicago Medicine.

The mission of the OCR is to catalyze clinical research by providing expertise, resources, infrastructure, and systems that facilitate clinical research operations and enable collaboration across the enterprise while promoting compliance and human subject protection on behalf of our diverse community of patients and volunteers.

Job Summary

The Regulatory Compliance Administrator (RCA) is a member of the Institutional Review Board (IRB) Staff. The RCA team provides administrative support to the three 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 2,500 new and continuing projects each year, and will work on other special projects as assigned.

Responsibilities

• Advises investigators regarding the preparation of protocols, the interpretation of federal and other regulations, and the implementation of institutional or IRB policies.
• Reviews 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.
• Prepares comments for investigators concerning submissions and responds to researcher inquiries regarding IRB or RADRAC policies/procedures, requests for reports, or renewal information.
• Compose summaries, federally‐mandated minutes, of the IRB Committees' technical deliberations for dissemination to research teams which highlight Committee concerns, decisions and need for follow‐up activity.
• Participates in the planning and execution of training programs, preparation of training and informational materials, including the IRB Website, and development of communications with faculty and administrators.
• Coordinates department or clinic compliance with a moderate level of guidance.
• Plans and executes internal and external audits and activities to support regulatory agency inspections.
• Prepares, completes and submits all compliance documentation on a routine basis. Coordinates compliance committee meetings.
• 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:

• --

Preferred Qualifications

Technical Skills or Knowledge:

• Expertise in Microsoft Word, Excel.

Preferred Competencies

• Work independently with a high degree of initiative, including problem‐solving and decision‐making.
• Work as part of a team.
• Maintain confidentiality.
• Work on multiple projects simultaneously, set priorities, and meet deadlines.
• Strong organizational and project management skills.
• Excellent written and verbal communication skills.
• Analytical skills.
• Manage stressful situations.

Working Conditions

• Office setting.

Application Documents

• Resume/CV (required)
• Cover Letter (required)

When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.

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

FLSA Status

Exempt

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.

The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.