Regulatory Coordinator

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.

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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:

1. 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.
2. Provide IRB (including single IRB) and IACUC assistance as needed to internal project investigators.
3. 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.
4. 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.
5. 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.
6. Other duties as identified.

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.

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.

Special Instructions:

Requisition Number: PRN42859B

Full Time or Part Time?: Full Time

Work Schedule Summary: Arranged with the Supervisor

Department: 00212 - Ctr Clin & Translational Sc.

Location: Campus

Pay Rate Range: $58,300-$68,999

Close Date: 11/24/2025