maintain accurate documentation. Coordinate facility and equipment availability for study visits. Report adverse events, including serious AEs, to the IRB and sponsor. Document protocol deviations, reconcile test article accountability, and prepare summary reports. Complete, audit, correct, and relay CRFs to the sponsor. Assist with negotiating contract budgets and terms, maintain documents per FDA guidelines, manage IRB documents, and ensure proper specimen collection, processing, and shipment. Perform Clinical Research Assistant functions as needed. Learn more about the great benefits of working for University of Utah: benefits.utah.edu The department may choose to hire at any of the below job levels and associated pay rates based on their business need and budget. Responsibilities Clinical Study Coordinator, IV Independently coordinate technical and administrative details for multiple clinical trials or research studies, assisting Principal Investigators in achieving study integrity and objectives. Assess protocols for clarity and subject safety independently, lead recruitment and consent processes, and maintain comprehensive and accurate study documentation. Coordinate complex study visits, ensuring resource availability, and report adverse events, including serious AEs, to the IRB and sponsor. Audit and correct CRFs for completeness and accuracy, negotiate contract budgets and payment terms with minimal supervision, maintain contact with the IRB, and manage IRB document submissions. Ensure proper collection, processing, and shipment of specimens. Requires a bachelor's (or equivalency) + 8 years or a master's (or equivalency) + 6 years of directly related work experience. Assumes work equivalency (1 year of higher education can be substituted for 1 year of directly related work experience). This is a Career-Level position in the General Professional track.Job Code: PZ1734Grade: P13 Minimum Qualifications EQUIVALENCY STATEMENT: 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor's degree = 4 years of directly related work experience). Department may hire employee at one of the following job levels: Clinical Study Coordinator, IV: Requires a bachelor's (or equivalency) + 8 years or a master's (or equivalency) + 6 years of directly related work experience. Assumes work equivalency (1 year of higher education can be substituted for 1 year of directly related work experience). Preferences Requires a bachelor's (or equivalency) + 6 years or a master's (or equivalency) + 4 years of directly related work experience. Assumes work equivalency (1 year of higher education can be substituted for 1 year of directly related work experience). Special Instructions Requisition Number: PRN46492B Full Time or Part Time? Full Time Work Schedule Summary: M-F Department: 00269 - Orthopedic Surgery Operations Location: Campus Pay Rate Range: $55K Close Date: 01/14/2027 Open Until Filled: To apply, visit https://utah.peopleadmin.com/postings/210844 je-9edb02245fc646c0aeb14fd048fe60a9
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