Duke Heart Center Clinical Research Unit | Duke Department of Medicine

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.

Overview

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

Central Administration

Schuyler Jones, MD
Director, Heart Center CRU
Phone: 919-668-8917
E-mail: schuyler.jones@duke.edu

Jennifer Langefeld
Financial Practice Manager, Heart Center CRU
Phone: 919-684-1557
E-mail: jennifer.langefeld@duke.edu

Jennifer Hamill
Research Practice Manager, Heart Center CRU
Phone: 919-681-4680
E-mail: jennifer.hamill@duke.edu

Contact Information

Heart Center CRU
2200 West Main Street, Ste. 340
Durham, NC 27705