PERMANENT

FULL_TIME

ADAPTED_NOW

UNKNOWN

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). 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.

YEAR

<img src="https://jobelephant.com/banners/9590.gif" style="margin:0 auto" width="400"/> QA/QC Navigator 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.  <a href="https://apptrkr.com/get_redirect.php?id=7127525&targetURL=https://ctsi.utah.edu/" rel="nofollow">Click here to learn more about the CTSI</a> Learn more about the fantastic <a href="https://apptrkr.com/get_redirect.php?id=7127525&targetURL=https://www.hr.utah.edu/benefits/" rel="nofollow">benefits provided to University of Utah Employees</a> 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:<ul><li>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.</li><li>Provide IRB (including single IRB) and IACUC assistance as needed to internal project investigators.</li><li>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.</li><li>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.</li><li>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. </li><li>Provide support to the CTSI to ensure compliance with ClinicalTrials.gov requirements, including study registration, updates, and results reporting.</li><li>Other duties as identified.</li><li> </li></ul> Note: This position is not responsible for providing patient care. Problem SolvingThis 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 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. 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: P21911Grade: 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: P21912Grade: 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 <ul><li>A demonstrated understanding of human subjects research, regulatory documents, and quality compliance is strongly preferred. Familiarity with animal research is also helpful. </li><li>At least two years clinical trials/research experience strongly preferred.</li><li>One year of regulatory experience, an understanding of medical terminology, and technical writing experience preferred.</li><li>The ability to effectively communicate verbally and in writing is also needed with a high level of attention to detail and follow-through.</li><li> </li></ul> Special Instructions 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. Requisition Number: PRN44883B Full Time or Part Time? Full Time Work Schedule Summary: Arranged with supervisor; typically M-F 8-5 standard business hours Department: 00212 - Ctr Clin & Translational Sc. Location: Campus Pay Rate Range: $43,945 - $62,527 Close Date: 6/30/2026 Open Until Filled: To apply, visit <a href="https://apptrkr.com/7127525" rel="nofollow">https://utah.peopleadmin.com/postings/200981</a> <img src="https://www.jobelephant.com/img.php?id=7127525ℑ=pixel"/> jeid-dd7414bc842381498d5186bd3ecb20fe

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QA/QC Navigator University of Utah

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