BSD OCR - Office of Clinical Research
The Office of Clinical Research (OCR) was created to further the missions of the University of Chicago Biological Sciences Division and the University of Chicago Medical Center by developing and supporting specific infrastructure components related to clinical and translational research. To provide the highest level of support and resources, the Office of Clinical Research is divided into two groups- the Institutional Review Board Administrative Staff (IRB) and the Research Operations and Conduct group (ROC). The OCR focuses on six key areas of service including: Human Subject Protection (IRB); Training and Education; Regulatory and Contract Oversight; Quality Assurance/Reporting and Auditing; Financial/Billing Compliance; Institutional Infrastructure.
The Regulatory Compliance Administrator (RCA) is a member of the Institutional Review Board 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.

• The RCA will advise investigators regarding the preparation of protocols, the interpretation of federal and other regulations, and the implementation of institutional or 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 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.
• 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 requirements include a college or university degree in related field. Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

• Ability to work independently with a high degree of initiative required, 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.

• Office Environment.

• Resume (required)
• Cover Letter (preferred)

Legal & Regulatory Affairs
Individual Contributor
Exempt
Monthly
40
Yes
Yes
No
No
No