Research Coordination Services

Clinical Research Support Program

The Clinical Research Support Program (CRSP) provides expert consultation and staffing solutions to support the design and conduct of clinical and translational research.

CRSP offers a multidisciplinary team of research nurses, research coordinators, regulatory specialists, and study monitors with extensive experience in conducting observational and experimental research designs in both biomedical and behavioral disciplines to support your work. Email CRSP for more information or to request our services.

Protocol and budget development

• Protocol review/study training
• Qualification site visits
• Source documents development/SOP development
• Contract and budget negotiation with ORSP Pre-Award
• Site initiation visit

FDA, IRB, and compliance support

• IRB submission
• Consent document development with HRO and sponsor
• IRB amendments and annual reviews
• Regulatory binder maintenance
• Recruitment and study implementation
• Eligible participant screening
• Participant consent
• Processing/shipping specimens to central labs
• Monitor visits
• Study visit information and data submission
• Non-standard of care charges review in Epic
• Processing CFRs/SAEs
• Follow-up telephone calls
• Study visit scheduling

Clinical study project management and monitoring

• Budget management, including processing invoices and account monitoring
• Study closeout, including internal and sponsor processes

Clinical Research and Trials Unit

If a study investigator needs space for their clinical research, our team can coordinate visits in conjunction with the Clinical Research and Trials Unit (CRTU), our dedicated clinical research facility on the 7th floor South of UMMC's Adult Hospital.

This state-of-the-art unit is comprised of:

• 22 inpatient and outpatient participant rooms, including two bariatric rooms and a three-room negative pressure suite.
• An 8-chair infusion center
• Research pharmacy for investigational drug dispensing
• Research lab for research sample processing, storage, and shipment
• Two encounter rooms for private, non-clinical patient interactions such as consenting and the completion of questionnaires.
• CRTU conference room, work spaces, computers, printers, and docking stations for investigator use.

Clinical Trialists

The CRTU also employs clinical trialists for participant monitoring and oversight.

Dr. Gailen Marshall is the Medical Director for the Clinical Research Support Program and Clinical Research and Trials Units at UMMC. Dr. Marshall has a 20+ year history of service as principal investigator for various industry sponsored and NIH-funded clinical trials. He also serves as the Translational Science Track Director for UMMC's Master of Science in Clinical Investigation degree program. He has authored more than 250 peer reviewed manuscripts, reviews and book chapters. Dr. Marshall is the R. Faser Triplett Chair of Allergy and Immunology, Professor of Medicine, Pediatrics, Pathology, Population Health Sciences, Vice Chair for Research in the Department of Medicine.

Dr. Vishnu Garla is an Associate Medical Director for the Clinical Research Support Program and Clinical Research and Trials Units at UMMC. He also serves as a UMMC Associate Professor of Medicine and Associate Program Director of the Endocrinology Fellowship Program, School of Pharmacy, Department of Medicine.

Dr. Utsav Nandi is an Associate Medical Director for the Clinical Research Support Program and Clinical Research and Trials Units at UMMC. He also serves as a UMMC Associate Professor in the Department of Emergency Medicine and an Associate Director of Research in the School of Medicine.