Hybrid Regulatory Affairs Support Specialist at UChicago
UChicago · Harvey, IL, United States Of America · Hybrid
- Office in Harvey, IL
Department
BSD CCC - CCT Pod1
About the Department
UCCCC has one of the largest cancer clinical trials programs in the country and in the Chicago area with nearly 500 adult and pediatric therapeutic trials actively accruing patients. Many of these studies are investigator-initiated, including Phase I or I/II trials, demonstrating UCCCC commitment to translate basic research findings to the clinic through proof-of-principle and early phase studies. UCCCC opens over 250 new trials each year and accrues approximately 900 participants to therapeutic trials each year.
Job Summary
This position maintains clinical trial regulatory compliance programs, including interpreting systems to identify risk areas and conducting internal audits. With a minimal level of direction, the employee participates in compliance documentation, compliance training, and documentation submission to required internal committees and groups.
Responsibilities
Provides Regulatory Administrative support for assigned network sites and/or multi-disciplinary disease team(s), including preparation of protocol updates and coordination of weekly team meetings, and distribution of relevant updates.
Prepares and submits to internal and external clinical research review committees, including submission of new study applications, amendments, and continuing reviews.
Creates and maintains site essential documents and files for assigned portfolio.
Communicates updates and changes (e.g., protocol amendments) to the clinical research team and sponsor/funding agencies.
Act 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.), maintenance of up-to-date regulatory files for external participating sites.
Initiates correspondence and other written materials under own signature or for signature of the leader. Triages emails and telephone calls for action. Resolves routine and complex inquiries. May act as liaison to Board of Directors.
Coordinates special projects as directed by the leader. Prepares write ups for recommendations for operational and administrative problems. May manage a portion of the leader's budget, monitoring and reconciling accounts. Prepares financial and/or administrative reports.
Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include vocational training, apprenticeships or the equivalent experience in related field (not typically required to have a four-year degree).
Work Experience:
Certifications:
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Preferred Qualifications
Experience:
Clinical research or directly related experience.
Prior clinical trial regulatory experience.
Preferred Competencies
Solid understanding of regulations covering clinical trials/human subjects research.
Excellent computer skills, including familiarity with Microsoft Office (Word, Excel, Outlook) and Adobe Acrobat.
Familiarity with clinical trial management systems and/or databases.
Excellent written and interpersonal skills. Ability to effectively present oral and written information.
Analytical, problem solving, and decision making skills.
Working Conditions
Ability to navigate assigned locations (UChicago, Ingalls, etc.).
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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