Research Coordinator - DVAC

RESEARCH COORDINATOR-DVAC

This position is located at the Durham VA Medical Center and is part of the VISN6 Cancer Clinical Research Network (CCRN) Program. CCRN is a collaborative program between VA Office of Research and Development and the VA National Oncology Program to improve the care of Veterans with cancer and increase cancer clinical trials in the VA.

The Durham VA Research Program Manager is responsible for managing the clinical‑research program as part of the multi‑site CCRN. The role of the Research Program Manager is to support and supervise all activities of the CCRN, provide procedural and regulatory knowledge, and support multiple research projects. The Research Program Manager performs a variety of complex tasks related to design, development, and implementation of research processes, and initiation and conduct of research protocols.

This includes assessing feasibility of research studies, study initiation, subject recruitment and enrollment, data collection and review, sample collection, preparation, and shipping, regulatory tasks, financial oversight, national program building, and hiring assistance. The Research Program Manager works with others members of the research and clinical teams at the Durham VA and other VISN6 facilities, collaborators and supporting services at the Durham VAMC, research staff at other CCRN sites, and the national CCRN executive committee.

These complex tasks directly impact the reputation of the CCRN program, both locally and nationally.

The Research Program Manager is assigned to managing the CCRN program in VISN6, including decentralized and multi‑site clinical trials and interfacility clinical programs. The Research Program Manager has knowledge of clinical trial activation and management, methods of program implementation and improvement, and conduct of human subject research. This includes the full scope of activities required to conduct clinical research, including study management, human subjects protection, and regulatory and policy compliance with the VA.

The incumbent uses independent judgement to apply regulations to specific situations, monitors training and certifications of research team members, and advises investigators on research procedures specific to oncology clinical trials. The Research Program Manager provides expert advice to the Principal Investigator of the Durham CCRN site, the Durham research team, research staff at other VISN6 CCRN sites, and the executive committee of the CCRN program regarding study progress, obstacles and resolutions, and opportunities to improve study and program activities.

The Research Program Manager prepares required reports as needed. Regular written and oral communication with the Durham VA research team and with research staff at other VISN6 CCRN sites through weekly in person meetings, regular emails, twice‑monthly conference calls, and annual national meetings is obligatory.

MAJOR

DUTIES AND RESPONSIBILITIES:

• Plan, develop, complete and submit documentation for initial and continuing review to IRBs.
• Analyze processes and documentation to ensure compliance with regulatory, privacy, and information security requirements for each individual clinical trial.
• Communicate with providers at other VA facilities in VISN6 regarding available clinical trials and potential research subjects.
• Develop and use evaluation metrics to improve recruitment and screening procedures.
• Evaluate data collection quality and establish and monitor remediation plans to correct deficiencies.
• Provide technical guidance to other members of research team regarding the conduct of human subjects research, including regulations, policies, and procedures. This may require researching and identifying individuals and written materials that serve as resources to be applied to the context of individual clinical trials.
• Independently respond to inquiries from research staff (locally and nationally) and other stakeholders. Independently correspond with others regarding the CCRN program and individual clinical trials, including memoranda and reports.
• Schedule meetings, arrange for space, notify…