Sobre este puesto de Regulatory Affairs Manager, Comprehensive Cancer Center en University of Chicago
Department
BSD CCC - CCT Pod2
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's commitment to translating 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
Responsibilities
- Prepares and submits materials to the IRB and other applicable internal review committees, including new study applications, amendments, and continuing reviews.
- Creates and maintains the site of regulatory files for each assigned study.
- Communicates updates and changes, such as protocol amendments, to the clinical research team and sponsor/funding agencies.
- Participates in internal clinical research audit program as assigned.
- Provides multi-site regulatory coordination 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; collection of site specific essential documents, including 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, such as consent forms and Form FDA 1572, etc.
- Prepares protocol updates, coordinates weekly program meetings, and distributes 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:
- Two years of clinical research or directly related experience.
- Prior clinical trial regulatory experience.
Certifications:
- Completion of a certificate or degree program in clinical trial management /regulatory affairs or directly related field.
Technical Skills or Knowledge:
- Excellent computer skills, including familiarity with Microsoft Office (Word, Excel, Outlook) and Adobe Acrobat.
- Familiarity with clinical trial management systems and/or databases.
Preferred Competencies
- Solid understanding of regulations covering clinical trials/human subjects research.
- Excellent written and interpersonal skills. Effectively present oral and written information.
- Analytical, problem solving, and decision making skills.
Application Documents
- Resume/CV (required)
- Cover Letter (preferred)
The University of Chicago uses AI-assisted tools to streamline and augment some recruitment processes; however, AI is not used to make hiring decisions.
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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