Department
BSD CCC - CCT Pod2
About the Department
Job Summary
Responsibilities
Prepares and submits to the IRB and other applicable internal review committees, including submission of new study applications, amendments, and continuing reviews.
Creates and maintains site regulatory files for each assigned study.
Communicates updates and changes (e.g., protocol amendments) to the clinical research team and sponsor/funding agencies.
Participates in the internal clinical research audit program (as assigned).
Acts as the primary regulatory liaison for external sites participating in clinical research projects coordinated by the University of Chicago, including distribution of protocol documents and amendments, review of site consent forms, and collection of site-specific essential documents (IRB approvals, Form FDA 1572, staff qualifications and signatures, etc.), and maintenance of up-to-date regulatory files for external participating sites.
Prepares and collects all necessary documents to activate protocols (e.g., consent forms, Form FDA 1572, etc.).
Prepares protocol updates and coordinates weekly program meetings and distribution of relevant updates to participating sites (as applicable).
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:
Certifications:
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Preferred Qualifications
Experience:
4+ years of prior work experience in clinical research and regulatory compliance.
Advanced degree or certification in clinical research or related field.
Clinical research certification (SOCRA, ACRP, etc.).
Demonstrated familiarity with federal and international regulations governing the oversight and conduct of clinical research.
Strong oral and written communication skills with both teams, faculty, and external vendors and sponsors.
Project management experience.
Preferred Competencies
Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.
Strong organizational skills.
Excellent interpersonal skills.
Strong data management skills and attention to detail.
Knowledge of the Microsoft Suite, including Outlook.
Ability to understand complex documents (e.g., clinical trials).
Ability to handle competing demands with diplomacy and enthusiasm.
Ability to absorb large amounts of information quickly.
Adaptability to changing working situations and work assignments.
Working Conditions
Ability to navigate the UChicago Campus as required by the Position.
Hybrid work arrangements may be considered.
Application Documents
Resume (required)
Cover letter (preferred)
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Family
Role Impact
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
Pay Rate Type
FLSA Status
Pay Range
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
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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