Regulatory Coordinator

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Regulatory Coordinator

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 Details 

Open Date  | 08/19/2025
Requisition Number  | PRN42859B
Job Title  | Regulatory Coordinator
Working Title  | Regulatory Coordinator
Job Grade  | E
FLSA Code  | Administrative
Patient Sensitive Job Code?  | No
Standard Hours per Week  | 40
Full Time or Part Time?  | Full Time
Shift  | Day
Work Schedule Summary  | Arranged with the Supervisor
VP Area  | U of U Health - Academics
Department  | 00212 - Ctr Clin & Translational Sc.
Location  | Campus
City  | Salt Lake City, UT
Type of Recruitment  | External Posting
Pay Rate Range  | $58,300- $68,999
Close Date  | 11/24/2025
Priority Review Date (Note - Posting may close at any time)  | 10/27/2025
Job Summary  | The Utah Clinical & Translational Science Institute (CTSI) is seeking a Quality Assurance/Quality Control navigator (QA/QC) to join our team! The CTSI is funded by the National Center for Advancing Translational Science (NCATS) to provide research resources, training, and pilot funding to advance human health. As a result of this federal funding, the CTSI and its programs and pilot grants must comply with the policies set by NCATS and the National Institute of Health (NIH).  As part of the CTSI’s grants team, working in close collaboration with the University of Utah’s Office of Quality Compliance and the NCATS QA/QC working group, the QA/QC navigator will help the CTSI maintain compliance with NIH policies. They will oversee processes to ensure compliance with annual reporting requirements, prior approval processes, and the NIH Public Access Policy. In addition, they will lead efforts to 1) improve and streamline processes and programming that promote compliance and 2) to create best practices for consistency, efficiency, and effectiveness.   Click here to learn more about the CTSI

Learn more about the fantastic benefits provided to University of Utah Employees, including generous retirement contributions, comprehensive medical coverage, tuition reduction, and more.
Responsibilities  | Essential Functions: Work closely with internal and external stakeholders to complete and improve the prior approval process (human and animal studies), including ongoing progress reporting as required by NCATS. For new pilot and other projects, help investigators prepare prior approval submissions to ensure the projects comply with NIH policies before they begin. Provide IRB (including single IRB) and IACUC assistance as needed to internal project investigators. Work closely with the CTSI’s Continuous Improvement, Tracking, and Evaluation (CITE) team to collect and report outcomes metrics on our various programs as required by NCATS. Participate in the NCATS QA/QC working group and subcommittees to improve and streamline the prior approval processes and other QA/QC processes. The QA/QC navigator will be expected to take the feedback from the Utah CTSI community to these meetings to make a QA/QC plan, shaping improvements, and developing milestones and metrics for performance enhancement. Provide support to the CTSI to 1) ensure compliance with the NIH Public Access Policy for all articles associated with the CTSI, including assisting authors with the process, and 2) develop and refine programming (web materials, presentations, etc) to promote awareness of this requirement throughout the timeline of an investigator/author’s involvement with any CTSI core(s). This process will ensure that the scientific innovations stemming from the CTSI are shared publicly to promote dissemination.  Other duties as identified. Work Environment and Level of Frequency typically requiredNearly Continuously: Office environment.Physical Requirements and Level of Frequency that may be requiredNearly Continuously: Sitting, hearing, listening, talking.Often: Repetitive hand motion (such as typing), walking.Seldom: Bending, reaching overhead.
Minimum Qualifications  | Bachelor’s degree in a research or related area plus two years clinical trials/research experience or equivalency (one year of education can be substituted for two years of related work experience) required; demonstrated human relations and effective communication skills also required.

One year of regulatory experience, an understanding of medical terminology and technical writing experience preferred.

This position is not responsible for providing patient care.
Preferences  | A demonstrated understanding of human subjects research, regulatory documents, and quality compliance is strongly preferred. Familiarity with animal research is also helpful. The ability to effectively communicate verbally and in writing is also needed, with a high level of attention to detail and follow-through.
Type  | Benefited Staff
Special Instructions Summary  |
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 patients from all backgrounds and possess a strong commitment to improving access to higher education and quality healthcare for historically underrepresented students and patients. All qualified individuals are strongly encouraged to apply. 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.
The University of Utah is an Affirmative Action/Equal Opportunity employer and 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 Affirmative Action (OEO/AA). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at: https://www.utah.edu/nondiscrimination/
Online reports may be submitted at oeo.utah.edu https://safety.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.

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 Contact us: (801) 581-2169 By Email: employment@utah.edu 

 

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