Preparation and submission of new research protocol documents (protocol, consent forms, etc.) to the University of Chicago Institutional Review Board (IRB) and other applicable internal review committees including submission of amendments and continuing reviews.
Creation and maintenance of regulatory files (IRB submission documents, consent forms, Food and Drug Administration (FDA) 1572 form, delegation logs, etc.) for each assigned research protocol.
Communication of updates and changes to the clinical research team and pharmaceutical companies, outside Universities and agencies (FDA, Foundations, etc.).
Preparation of protocol updates and coordination of weekly program meetings and distribution of relevant updates to participating sites (as applicable).
Ability to communicate clearly with faculty, staff and people outside the University.
Prepares and participates in internal and external audits and activities to support regulatory agency inspections.
Multi-site Regulatory Coordination (as assigned):Act as the primary regulatory liaison for external sites participating in clinical research protocols 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.
Reviews all applications against University guidelines, in addition to drafting progress reports, non-competing applications, amendments, and budgeting. Responsible for all data entry and preparation of grant reports and trend analysis.
Prepares summaries of grants and effort allocations for Principal Investigators, meets with them and responds to their questions. Coordinates with other departments/units/divisions regarding multi investigator grants. Serves as department contact for annual audits and agency site visits.
Performs other related work as needed.
Cover Letter (required)
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Internal Number: JR11510
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.