UC San Diego Clinical and Translational Research Institute

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PROJECT SUMMARY/ABSTRACT This administrative supplemental funding request is in response to the NOT-TR-20-014 opportunity, and it is linked to the UC San Diego Altman Clinical and Translational Research Institute (ACTRI) Hub. Our hub, which was successfully renewed in 2020 for 5 years, has experienced increasing challenges in managing efficiency in the NCATS Prior Approval process. These challenges include interactions among a complex group of stakeholders, including the applicant, ACTRI administration, Office of Grants and Contracts Administration (OCGA), the Institutional Review Board (IRB), and the NIH. The consequences of delayed onset of projects are substantial, in particular that delays in a phase of Prior Approval detract from our hub’s ability to advance research for the 10-15 annual Pilot Awards and 8 KL2 awards we administer. Therefore, we welcome the opportunity to apply for funding to support a new full-time role at the ACTRI, a Quality Assurance/Quality Control (QA) Officer. The QA/QC Officer will work under the supervision of the Clinical Research Strategic Initiatives Office, PI, and key Program Directors involved in Prior Approval submissions. The QA/QC officer will undertake a variety of process improvement responsibilities directly aimed at increasing efficiency in Prior Approval procedures. After formal process mapping and programming planning, the QA/QC’s responsibilities will include: 1) Pre-award/Applicant Community Support in the form of web-based resource development, in service presentations, and consultation services aimed at prospective applicants to programs and increasing awareness of the Prior Approval process and its timelines, 2) Prior Approval Submission support, including tracking and project management of awarded applicants, document QA, and linkage between stakeholders, and 3) Post-Approval Management of processes including timeliness of updates to regulatory documents and tracking of work products such as publications and related compliance assurance. The QA/QC Officer will develop, adapt, and implement project management tools, with which our hub is experienced, such as project management dashboards, time tracking software, and process mapping. As directed by the NOT, the QA/QC Officer will collaborate with the national QA/QC network and will be active in resource sharing and adoption with other hubs in our region and nationwide.