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This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/jobs/12200952 Department

BSD OCR - Regulatory Compliance

About the Department

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 provides support in six key areas of service including: Human Subject Protection; Training and Education; Regulatory and Contract Oversight; Quality Assurance/Reporting and Auditing; Financial/Billing Compliance; Institutional Infrastructure. The Institutional Review Board (IRB) Administrative Staff of Regulatory Compliance Administrators support the overall human subject protection program.

Job Summary

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.

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 ensures 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.
• Composes 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, 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 Qualifications

Education:

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

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Work Experience:

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

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Certifications:

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Preferred Qualifications

Education:

• Bachelor\'s degree in a related field.

Preferred Competencies

• Demonstrated flexibility and multi-task on frequent and constantly changing demands.
• Effectively communicate with faculty, graduate students and various administrativ offices at all levels in the University.
• Excellent organizational skills.
• Attention to detail.
• Meet deadlines.
• Maintain confidentiality.
• Resolves problems.
• Work independently and as part of a team.

Working Conditions

• Office environment.

Application Documents

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

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

Job Family

Legal & Regulatory Affairs

Role Impact

Individual Contributor

FLSA Status

Exempt

Pay Frequency

Monthly

Scheduled

Weekly Hours

40

Benefits Eligible

Yes

Drug Test Required

No

Health Screen Required

No

Motor Vehicle Record Inquiry Required

No

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