Regulatory Affairs Specialists

Announcement

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 View phone number on click.appcast.io 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 View phone number on click.appcast.io or View phone number on click.appcast.io or University Human Resource Management at View phone number on click.appcast.io 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

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.