The mission of the Duke Heart Center (HC) Clinical Research Unit (CRU) is to support, oversee, and serve as the organizational home for all clinical research conducted within the Duke Heart Center.
The HC CRU is responsible for the scientific integrity, quality, academic productivity, regulatory compliance, and financial solvency of all clinical research conducted in the Heart Center.
The Clinical Research Unit is the organizing structure for the conduct of clinical research involving human subjects in the Duke Heart Center. Currently Duke faculty and staff are conducting a number of clinical research projects at the Duke Heart Center.
These projects involve chart reviews, devices, drugs, observation, supportive care (quality of life), and tissue/blood sampling research, and are all conducted within the Duke community and Duke University Health System.
What are the scientific goals of the HC CRU?
- To provide innovative and cutting edge clinical research
- To scientifically align HC faculty interests with that of the Duke University Medical Center academic mission
- To integrate research with the clinical enterprise, successfully reflecting positively on the HC’s commitment to its research mission
- To regulate research methods to help ensure valid findings
- To provide education and mentorship for faculty and staff
- To provide a standard of practice that ensures transparency to the sponsor and subjects
What are the functions of the HC CRU?
- To create, improve, and apply standardized clinical research processes that are regulatory compliant, cost effective, and efficient
- To provide a consistent level of operational expertise
- To ensure compliance with Duke policy on clinical research
- To assist with communications across organizations, as needed
- To identify, screen, enroll, and obtain consent from potential subjects
- To collect data and retain study records in a secure database
- To perform internal study audits
- To review and assess clinical research projects for feasibility
- To prepare clinical research budgets
- To facilitate research project MOUs across the organization
- To develop billing grids for clinical research projects
- To coordinate contract negotiations
- To assist with the regulatory preparation and submission of clinical research projects
- To track and validate billing milestones and to invoice timely and accordingly
- To review, track, and reconcile study-specific revenue and expenses
What types of studies should be conducted within the HC CRU?
All types of clinical research projects involving human subjects will be conducted within the HC CRU
Schuyler Jones, MD
Director, Heart Center CRU
Financial Practice Manager, Heart Center CRU
Research Practice Manager, Heart Center CRU
Heart Center CRU
2200 West Main Street, Ste. 340
Durham, NC 27705