CLINICAL RESEARCH MANAGEMENT (Under Construction)



Clinical Research Management Office - Maureen Morgan, MS, KCC, TJU.
The Clinical Research Management Office (CRMO) is a shared resource at the KCC. The CRMO collaborates with physicians, scientists and support staff in the development and implementation of KCC clinical trials and provides a broad range of services tailored to the specific needs of the investigator and his/her support staff. Both CRMO and Interactive Research Staff members are responsible for the organization and facilitation of the disease-specific multidisciplinary working group meetings. This has established the CRMO as the central resource for KCC clinical trials. CRMO staff, other relevant clinical trials staff, and representatives of the KCC Informatics Shared Resource meet monthly to discuss issues or concerns specific to KCC studies. CRMO staff and other KCC interactive clinical trials staff attend monthly educational meetings sponsored by the TJU Office of Clinical Trials designed to standardize best clinical trial practices across the entire TJU campus. The CRMO study coordination and data management staff meets weekly to review clinical trial process issues, sponsor requests, PI requirements, and other new or ongoing issues pertaining to the conduct of clinical trials.



Clinical research services - Greg Stets, BSN, MHA, Nemours/AIDHC.
The Clinical Research Services Core (CRSC) is an outgrowth of the Nemours Clinical Pharmacology Research Program, which was originally developed to provide oversight and facilitation of clinical trials for Nemours investigators. With the development of the Center for Pediatric Research and support by the NIH-COBRE award, the CRSC has expanded to include 4 full time Clinical Study Coordinators. The Coordinators directly serve the needs of both Center investigators as well as other Nemours investigators whose research involves human subjects, including children. They assist with study design, subject recruitment, database management, and also facilitate interactions with the Institutional Review Board by working with the target investigators and other Nemours faculty on protocol development and consent and assent documents to ensure that they meet institutional and federal requirements.