254 Establishing a community-focused clinical research site in a low-resourced HBCU: Lessons learnt through collaboration, capacity building, workforce training, community engagement, and infrastructure development

Objectives/Goals: Texas Southern University (TSU), a low-resourced HBCU and one of the largest in the USA, without an affiliated hospital, clinic network, or patient population, established a community-focused clinical research site to educate, recruit, and expand research participation, especially among those with unmet health needs. Methods/Study Population: The implementation process involved strategic planning in five key areas as below: * Collaboration: Partnered with mentor site to align site capabilities with industry standards * Capacity Building: EstablishCTMS, eReg, eSource, and REDCap workflow * Workforce Training: Hired and strengthened research personnel expertise through training, certification, and mentorship * Community Engagement: Enhanced trusted relationships with community members, key stakeholders, and advisory board members * Infrastructure Development: Defined site capabilities: regulatory processes, data management, IRB optimization, budgeting, contract management, and prospective study feasibility assessments. Developed standard operating procedures and clinical research registry for site readiness Results/Anticipated Results: A first of its kind Community-Focused Clinical Research Site in a low-resourced HBCU without an affiliated hospital, clinic network, or patient population was successfully established at TSU with mentorship by the University of Texas Medical Branch Galveston, PhRMA Foundation EQBMED, and RCMI Coordinating Center. A registry for potential research participants was successfully implemented in May 2025. Since its inception, 160 community members have indicated interest in clinical research registry participation. 56 community members are fully enrolled in the registry. Key challenges included bridging feasibility gaps at TSU, navigating the development of new clinical research infrastructure, and managing regulatory and contracting approval timeline. Discussion/Significance of Impact: Establishing a clinical research site in a low-resourced HBCU without an affiliated hospital requires cross-disciplinary collaboration and intentional community engagement. TSU’s approach offers a replicable model for integrating clinical research to expand access to community member especially among those with unmet health needs.