CCR Research Nursing

肿瘤学研究护士协调员是一个子专业护理角色，负责维护临床试验的完整性，同时平衡临床试验的协调与患者在这些试验中的管理。作为一名有执照的专业护士，肿瘤学RNC拥有科学知识、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的角色包括招募和留住患者、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、协议遵从性、维护详细的监管记录、与有执照的医生合作、不良事件报告，以及与实施问题相关的协议可行性的确定。对协议的监管要求已明显变得更加复杂。RNC有助于准确和及时地提交各种监管文件，如FDA年度报告、持续审查(CR)、IND安全报告和监管活页夹的维护。RNC管理和监控各种电子数据管理系统，并监督如何将数据输入系统、验证或清理、传输和编码以及如何确保安全。RNC在按方案治疗之前、期间和之后为患者识别、监测和报告不良事件方面发挥着至关重要的作用。及时提交意想不到的问题、提交严重不良事件和例行不良事件报告都是通过RNC进行协调的。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接受过广泛培训的有执照的专业护士，RNC在临床研究中发挥着至关重要的作用，并在从提供患者护理、协调研究到维护临床试验完整性的各个层面的研究活动中不可或缺。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子专业，并以肿瘤护理学会的临床试验护士模型、框架和能力为基础进行培训和业绩衡量。)：由OAR审查，并决定在19财年保持一致。高度优先的艾滋病毒/艾滋病研究约占该核心预算的10%。CCR医生通过马里兰州贝塞斯达临床研究中心(CRC)的临床试验计划，每年用新疗法治疗来自全国各地的数千人。临床研究护士协调员(RNC)的角色是肿瘤学(包括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还接受了在人体研究方面的专业知识培训，这些领域包括方案的可行性和合规性、遵守道德标准、法规要求、数据管理等。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，他们通过支持继续教育、指导、专业发展和合作的文化履行CCR的使命，同时平衡全面的患者协调与高质量的临床和转化研究。

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.