CCR Research Nursing

肿瘤研究护士协调员是一个亚专科护理角色，在平衡临床试验与患者管理的协调的同时，维护临床试验的完整性。作为一名有执照的专业护士，肿瘤学RNC具有科学知识背景，批判性思维技能以及对个人和群体行为的理解。RNC支持广泛的活动，以支持临床研究和患者护理，同时在临床试验开发和实施的每个阶段协助临床研究人员。RNC的角色包括患者招募和保留、知情同意、临床试验患者的管理和教育、文件和文件管理、数据管理和信息技术、遵守道德标准、协议合规性、维护详细的监管记录、与执业医师合作、报告不良事件以及确定与实施问题相关的协议可行性。协议的监管要求已经变得更加复杂。RNC促进准确及时地提交各种监管文件，如年度FDA报告、持续审查（CR）、IND安全报告和监管粘合剂的维护。RNC管理和监控各种电子数据管理系统，并监督数据如何进入系统，验证或清理，传输和编码，以及保持安全。RNC在确定、监测和报告患者在治疗方案之前、期间和之后的不良事件方面发挥着至关重要的作用。及时提交未预料到的问题，提交严重不良事件和常规不良事件报告都通过RNC进行协调。RNC确保收集准确的数据，并参与定期的质量保证数据监测和审计。作为一名在肿瘤学和研究方面受过广泛培训的执业专业护士，RNC在临床研究中发挥着至关重要的作用，从提供患者护理到协调研究，再到维护临床试验的完整性，RNC在各个层面的研究行为中都扮演着不可或缺的角色。研究护理办公室非常重视研究护士协调员作为护理的一个亚专业，并根据肿瘤护理学会的临床试验护士模式、框架和能力进行培训和绩效评估。)：由OAR审查，并决定在2019财年进行调整。高度优先的艾滋病毒/艾滋病研究约占该核心预算的10%。CCR医生每年通过马里兰州贝塞斯达临床研究中心（CRC）的临床试验项目，为来自全国各地的数千人提供新疗法。临床研究护士协调员（RNC）的角色是肿瘤学（包括与艾滋病相关的恶性肿瘤）和艾滋病毒/艾滋病的专业护理角色，对有效和安全地实施临床试验至关重要。除了传统的护理能力外，RNC还在方案可行性和合规性、遵守道德标准、监管要求、数据管理等领域对人体受试者进行研究方面进行了高度训练。该办公室的目标是招聘、培训和留住一支独特的、有凝聚力的优秀研究护士专家团队，通过支持继续教育、指导、专业发展和合作的文化，同时平衡全面的患者协调和高质量的临床和转化研究，执行CCR的使命。

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.