570 The development and establishment of a Centralized Clinical and Translational Research Infrastructure at an Academic Medical Center

Objectives/Goals: Historically, the Univ. of Missouri (MU) Sch. of Medicine (SOM) is known for its strong clinical and education programs. In 2020, MU recruited an Executive Vice Chancellor (EVC) for Health Affairs and subsequently Dean of the SOM who initiated programmatic steps to develop and establish a centralized clinical and translational research (CTR) infrastructure. Methods/Study Population: In order to develop and establish a CTR infrastructure, the EVC/Dean of the SOM created and recruited to the combined position of the Associate Dean (AD) for CTR and Associate Director (ADR) of clinical research (CR) for the Ellis Fischel Cancer Ctr. (EFCC) in 2021. The AD CTR was appointed the Chair of the Clinical and Translational Science Unit (CTSU) Steering Committee with the charge of establishing a 10,000 sq. ft. CTSU to be housed in the newly built $225M Roy Blunt NextGen Precision Health Bldg. and for re-building the Clinical Trials Support Office (CTSO), and the Clinical Trials Office (CTO) at the EFCC in his other role as the ADR CR. The AD CTR was also charged with implementing the OnCore clinical trial management system (CTMS) to centrally track and fiscally manage SOM clinical trials. Results/Anticipated Results: Between 2021 and 2023, a CTR infrastructure was developed and established at the MU SOM. A total of 25 new clinical research staff (CRS) and leadership were hired that included a Sr. Dir. of CR Operations, clinical research nurses (CRNs) and coordinators (CRCs), Regulatory/Data/Fiscal/Project/Compliance/Coverage Analysis Coordinators between the CTSU/CTSO and the CTO of the EFCC. The CTSU was built with 10 FTE CRS [CRNs = 5, CRCs = 2, administrative staff = 2, Sr. Lab. Tech. = 1, and a manager]; the CTSO was re-built with 9 FTE CRS [Fiscal (n = 3), Project (n = 2), Compliance (n = 2), Coverage Analysis (n = 1) and Recruitment (n = 1) coordinators]. The EFCC CTO was re-built with 8 FTE CRS [CRNs = 4, Fiscal (n = 1), Data (n = 1) & Regulatory (n = 2) coordinators]. The implementation of the OnCore CTMS tracking function was also completed. Discussion/Significance of Impact: Overall, the development and establishment of the CTR infrastructure has led to a significant increase and enhancement (e.g., capacity) to conduct clinical trials at the MU SOM. For example, this has led to a significant increase in the average annual enrollment to interventional oncology clinical trials [n = 82 (2021–2023) vs. n = 42 (2016–2020), p = 0.004].