CCR Research Nursing

Division Of Basic Sciences - Nci

Investigators

Linked publications & trials

Abstract

The oncology research nurse coordinator is a subspecialty nursing role that safeguards the clinical trial's integrity while balancing the coordination of clinical trials with the management of patients on those trials. As a licensed professional nurse, the oncology RNC brings a background of scientific knowledge, critical-thinking skills, and the understanding of individual and group behavior. The RNC supports a wide range of activities to support clinical research and patient care while assisting clinical investigators throughout every phase of clinical trial development and implementation. The RNC role includes patient recruitment and retention, informed consent, management and education of clinical trial patients, documentation and document management, data management and information technology, adherence to ethical standards, protocol compliance, maintenance of detailed regulatory records, collaboration with Licensed Medical Practitioners, reporting of adverse events, and determination of protocol feasibility as it pertains to implementation issues. Regulatory requirements for protocols have become significantly more complex. The RNC facilitates the accurate and timely submission of various regulatory documents such as annual FDA reports, continuing reviews (CR), IND safety reports, and maintenance of regulatory binders. The RNC manages and monitors a variety of electronic data management systems and oversees how data are entered in the systems, validated or cleaned, transferred and coded, and kept secure. The RNC plays a crucial role in identifying, monitoring and reporting adverse events for patients prior to, during and following treatment on a protocol. The timely submission of unanticipated problems, submission of serious adverse events and routine adverse event reporting are all coordinated through the RNC. The RNC ensures the collection of accurate data and participates in regular quality assurance data monitoring and audits. As a licensed professional nurse with extensive training in oncology and research, the RNC plays a vital role in clinical research and is integral to research conduct at every level, from providing patient care, to coordinating studies, to safeguarding the clinical trial's integrity. The Office of Research Nursing strongly values the research nurse coordinator as a subspecialty of nursing and has based training and performance measurements on the Oncology Nursing Society's Clinical Trials Nurse model, framework and competencies.): Reviewed by the OAR and determined to be aligned in FY19. High priority HIV/AIDS studies constitute approximately 10% of this core's budget. CCR physicians treat thousands of people from around the country every year with novel therapies through a clinical trials program at the Clinical Research Center (CRC) in Bethesda, Maryland. The role of the clinical research nurse coordinator (RNC) is a specialty nursing role in oncology (including AIDS related malignancies) and HIV/AIDS and critical to the effective and safe implementation of clinical trials. The RNC is highly trained with expertise in the conduct of research on human subjects in areas such as protocol feasibility and compliance, adherence to ethical standards, regulatory requirements, data management, in addition to traditional nursing competencies. The objectives of the Office are to recruit, train and retain a unique, cohesive team of superior research nurse specialists who carry out the mission of the CCR through a culture that supports continuing education, mentorship, professional development, and collaboration while balancing comprehensive patient coordination and quality clinical and translational research.