Preparation and collection of all necessary documents to activate protocols (e.g. consent forms, Form FDA 1572, etc.).
Preparation and submission to the IRB and other applicable internal review committees including submission of new study applications, amendments, and continuing reviews.
Creation and maintenance of site regulatory files for each assigned study.
Communication of updates and changes (e.g. protocol amendments) to the clinical research team and sponsor/funding agencies.
Participation in internal clinical research audit program (as assigned).
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.
Preparation of protocol updates and coordination of 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.
Two years of clinical research or directly related experience.
Prior clinical trial regulatory experience.
Completion of a certificate or degree program in clinical trial management /regulatory affairs (or directly related field).
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.
Cover letter (preferred)
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