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Regulatory Affairs Specialists

Regulatory Affairs Specialists

University of Utah

Campus, IL

$43K - $62K/yr

Full-time

Medical, Retirement

Posted 14 days ago

University Of Utah rating

7.2

Company rating: 7.2 out of 10

Based on 157 frontline employees who took The Breakroom Quiz

334th of 536 rated colleges and universities

Job description

Details
Open Date 04/30/2026 Requisition Number PRN44883B Job Title Regulatory Affairs Specialists Working Title QA/QC Navigator Career Progression Track P00 Track Level P2 - Developing, P1 - Entry Level Pro FLSA Code Professional Patient Sensitive Job Code? No Standard Hours per Week 40 Full Time or Part Time? Full Time Shift Day Work Schedule Summary
Arranged with supervisor; typically M-F 8-5 standard business hours
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 $43,945 - $62,527 Close Date 06/30/2026 Priority Review Date (Note - Posting may close at any time) 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, and 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, ClinicalTrials.gov requirements, 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 contribution, comprehensive medical coverage, tuition reduction, and more.
In the cover letter, please describe your experience as it relates to this position and confirm that you will be available to work from the state of Utah for this position.
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 are in compliance 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 with the purpose of making 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. 
  • Provide support to the CTSI to ensure compliance with ClinicalTrials.gov requirements, including study registration, updates, and results reporting.
  • Other duties as identified.

Note: This position is not responsible for providing patient care.
Problem Solving
This position will utilize federal, institutional guidelines and requirements, and best practices to complete prior approval submissions and work collaboratively to improve the processes. This position will also work with University research committees and NCATS to ensure full compliance and communication.
Work Environment and Level of Frequency typically required
Nearly Continuously: Office environment.
Physical Requirements and Level of Frequency that may be required
Nearly Continuously: Sitting, hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking.
Seldom: Bending, reaching overhead.

Applicants will be hired into one of two levels depending on experience:
Regulatory Affairs Specialists, I
Requires basic skill set and proficiency. Conducts work assignments as directed. Closely supervised with little latitude for independent judgment.
Requires a bachelor's (or equivalency) + 2 years of directly related work experience or a master's (or equivalency) degree.
This is an Entry-Level position in the General Professional track.
Job Code: P21911
Grade: P13

Regulatory Affairs Specialists, II Requires moderate skill set and proficiency in discipline. Conducts work assignments of increasing complexity, under moderate supervision with some latitude for independent judgment.
Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience.
This is a Developing-Level position in the General Professional track.
Job Code: P21912
Grade: P16
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:

Regulatory Affairs Specialists, I: Requires a bachelor's (or equivalency) + 2 years of directly related work experience or a master's (or equivalency) degree.

Regulatory Affairs Specialists, II: Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience.

Preferences
  • A demonstrated understanding of human subjects research, regulatory documents, and quality compliance is strongly preferred. Familiarity with animal research is also helpful. 
  • At least two years clinical trials/research experience strongly preferred.
  • One year of regulatory experience, an understanding of medical terminology, and technical writing experience preferred.
  • 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
In the cover letter, please describe your experience as it relates to this position and confirm that you will be available to work from the state of Utah for this position.
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 NonDiscrimination 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.

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About University of Utah

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The University of Utah is the state’s flagship institution of higher education, with 18 schools and colleges, more than 100 undergraduate majors and graduate programs, and an enrollment of more than 38,000 students. It is a member of the Association of American Universities—an invitation-only, prestigious group of 71 leading research institutions. The U is advancing a new national model for higher education that delivers societal impact through education, research, health care, and community service, while making social, economic, and cultural contributions that improve lives across Utah and around the world.

Industry

Colleges, universities, and professional schools

Company size

10,000+ Employees

Headquarters location

Salt Lake City, UT, US

Year founded

1850

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