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.

Responsibilities

• 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.
• 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.
• Provide support to the CTSI to ensure compliance with the NIH Public Access Policy for all articles associated with the CTSI.
• Provide support to the CTSI to ensure compliance with ClinicalTrials.gov requirements, including study registration, updates, and results reporting.