Coordinate technical and administrative details of clinical trials or research studies, assisting Principal Investigators in implementing and completing study protocols and procedures. Assess protocol clarity and subject safety, review inclusion/exclusion criteria, and address concerns with the PI and sponsor. Participate in meetings, advising on assignments and timelines. Obtain informed consent, medical history, and demographics, and 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.
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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.
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).
Additional Information
The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS’ post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules.
This position may require the successful completion of a criminal background check and/or drug screen.
The University of Utah values candidates who have experience working in settings with students and possess a strong commitment to improving access to higher education.
Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities.
Consistent with state and federal law, the University of Utah does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran’s status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both.
To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Title IX (OEO). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at the: University of Utah Non‑Discrimination page.
Online reports may be submitted at https://oeo.utah.edu
https://publicsafety.utah.edu/safetyreport/ This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. They also provide information about safety and security-related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.
As per University of Utah policy 5-108: Transfer of Benefits Eligible Staff Members, a new hire to the University of Utah who is still serving a 12 month probationary period will not be hired into another University of Utah job (a transfer) until the successful completion of the probationary period.
