1) Preparation and collection of all necessary documents to activate protocols (e.g. consent forms, Form FDA 1572, etc.)
2 ) Preparation and submission to the IRB and other applicable internal review committees including submission of new study applications, amendments, and continuing reviews
3) Creation and maintenance of site regulatory files for each assigned study
4) Communication of updates and changes (e.g. protocol amendments) to the clinical research team and sponsor/funding agencies
5) Participation in internal clinical research audit program (as assigned)
6) Multi-site Regulatory Coordination (as assigned):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.
7) Preparation of protocol updates and coordination of weekly program meetings and distribution of relevant updates to participating sites (as applicable).
1) Solid understanding of regulations covering clinical trials/human subjects research
2) Excellent computer skills, including familiarity with Microsoft Office (Word, Excel, Outlook) and Adobe Acrobat
3) Familiarity with clinical trial management systems and/or databases
4) Excellent written and interpersonal skills. Ability to effectively present oral and written information
5) Analytical, problem solving, and decision making skills
6) Attention to detail
7) Ability to multitask
8) Good interpersonal skills and ability to work independently and as part of a team
1) Two years of clinical research or directly related experience
2) Prior clinical trial regulatory experience
3) Completion of a certificate or degree program in clinical trial management /regulatory affairs (or directly related field)
1) Resume 2) Cover Letter
NOTE:Â When applying, all required documents MUST be uploaded under the Resume/CV section of the application.
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Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via the Applicant Inquiry Form.
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About University of Chicago (UC)
One of the world's premier academic and research institutions, the University of Chicago has driven new ways of thinking since our 1890 founding. Today, UChicago is an intellectual destination that draws inspired scholars to our Hyde Park and international campuses, keeping UChicago at the nexus of ideas that challenge and change the world.