Research Coordination Services

Through the Clinical Research Support Program (CRSP), MCRTC works with a multidisciplinary team of research nurses, research coordinators, regulatory specialists, and study monitors who can support the design and conduct of clinical and translational research. The CRSP provides expert consultation and staffing solutions to propel projects forward. Our team has extensive experience in conducting observational and experimental research designs in both biomedical and behavioral disciplines to support your work.

Services include:

• Protocol and budget development
• FDA, IRB, and compliance support
• Recruitment and study implementation
• Clinical study project management and monitoring

Request CRSP services

Clinical Research Support Program

The CRSP maintains a multidisciplinary team of research nurses, research coordinators, regulatory specialists, and study monitors who can support the design and conduct of clinical and translational research. The CRSP provides expert consultation and staffing solutions to propel projects forward. Our team has extensive experience in conducting observational and experimental research designs in both biomedical and behavioral disciplines to support your work.

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