Office of Clinical Research & Development
jlipton@nshs.edu
The Office of Clinical Research and Development breaks down barriers that investigators and potential study participants often encounter in the process of conducting clinical research. By providing select services to these parties, the Office of Research and Development (OCRD) advances the success of clinical research within the health system.
The OCRD is composed of three cores: Concierge Service, Research Coordinator Core and Recruitment Core.
The Concierge Service provides both investigators and potential study participants help to identify needed services, referrals to the appropriate FCTSC resources, and follow-up to assure that needs were met to the highest degree of satisfaction. Dr. Morgan is responsible for providing these services, along with overseeing the day-to-day operations of the program to ensure the total delivery of quality services.
The Research Coordinator Core assists investigators in the development, implementation, and oversight of clinical research protocol conduct.
These services are provided by a core of highly experienced research coordinators and include:
- Filing of IRB and FDA submissions
- Maintaining orderly and thorough source & regulatory documents in accordance with FDA/ICH guidelines
- Assisting with study participant visits
- Coordinating IRB and/or FDA audits The Recruitment Core assists investigators in achieving individualized targeted protocol completion by promoting community participation in clinical research.
The core is staffed by a team of highly experienced recruitment professionals and offers:
- A centralized potential study participant recruitment database.
- An active research protocol database accessible by the public.
- A research practice network of physicians able to recruit for a variety of protocol disciplines.
- Consult appointments with the health system Marketing Department to develop customized protocol-specific advertising.
- Quality assurance and quality improvement reviews to solve study participant recruitment and retention challenges.
Applications for the use of the Research Coordinator and Recruitment cores are reviewed by the OCRD Advisory Committee. Services are allocated to an investigator based on the complexity and duration of the protocol, staffing needs of the investigator, and the clinical research experience of the investigator.
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Name: Ruth M. Morgan, DC |