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Regulatory Project Manager

University of Utah • Salt Lake City, UT, US • published 2026-10-08 21:03:19.975031

Description

**Job Summary:** The Division of Hematology, Oncology, BMT has an immediate opening for a Regulatory Project Manager, in the Department of Pediatrics at the University of Utah Spencer F. Eccles School of Medicine. This role is responsible for the comprehensive regulatory management of clinical research studies, ensuring compliance with FDA, IRB, institutional, sponsor, and consortium requirements from study start\-up through closeout. Key responsibilities include preparing and submitting regulatory documents and IRB applications, managing study amendments, continuing reviews, adverse event reporting, protocol deviations, consent form updates, and study activation and closure activities. The position maintains regulatory files, study records, training and delegation logs, tracks approvals and expirations, coordinates with sponsors, investigators, research teams, and institutional departments, and supports monitoring visits, audits, and quality assurance activities. The role also provides regulatory guidance to study teams, facilitates communication among stakeholders, drives process improvements, ensures accuracy of research systems and documentation, and mentors research staff whil...

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