| Position Summary
Provides professional research and nursing services for research projects and studies in the Department of Radiology and support the greater Medical School and Joint Clinical Enterprise research objectives. Projects will include coordination, collaboration, and communication with investigators, patients, research participants, sponsors, clinical care or research teams, as well as other applicable institutional authorities. The research nurse will be responsible for a variety of activities in the research cycle, including study feasibility, onboarding, recruitment, screening, pre/peri/post study visits, medical record review, data entry, subject retention, regulatory and budgetary compliance, and study close-out. Additionally, this role will serve as a resource and back-up for departmental colleagues with less experience. Position will primarily work independently with day to day activities; and report to the Radiology Department Research Administrator.
TYPICAL TASKS (These examples do not include all possible tasks in this work and do not limit the assignment of related tasks in any position of this class.)
â— 60% - Identify and follow clinical trial subjects, accurately completing visit procedures and data collection according to the protocol while maintaining the health and safety of research subjects.
â— Understand and interpret clinical protocols, assess study needs, develop plans for successful implementation, conduct and document visits, evaluate progress regularly, and provide input to integrate improvements.
â— Develop methods to identify potential participants such as via database searches and collaboration with internal and external partners.
â— Obtain research consent/HIPAA and screen patients for eligibility based on medically complex inclusion and exclusion criteria, seeking investigator input as appropriate. Educate the patient as well as the legally authorized representative or family when applicable throughout the research participation process.
â— Provide protocol-specific specialized nursing services for research studies when needed, which may include vital signs, IV placement, blood draws, patient assessment, administering investigational agents, and/or obtaining biological specimens.
â— Develop and maintain accurate source documentation.
â— Document research findings and data according to protocol requirements and timeline.
â— Interpret study/medical results to families and /or health care staff and report significant findings to appropriate study staff.
â— Assess, troubleshoot, and report adverse events or problems with data collection or other research processes.
â— 30% - Provide study-specific leadership and day-to-day supervision to meet key benchmarks in the areas of study setup, participant recruitment and retention rates, development and implementation of data management systems, and reporting responsibilities.
â— Initiate and participate in project update meetings
â— Provide assistance in defining and working through study logistics and feasibility
â— Serve as subject matter expert in clinical-related and health care topics
â— Collaborate with other disciplines involved in the research process. Demonstrate effective and efficient communication with study sponsors, monitors, study/department staff, and health team members
â— Provide ongoing quality control audits and implement improvements as needed
â— Position may include infrequent travel (2-3 times/year) for study meetings or training
â— 10% - In conjunction with the departmental regulatory specialist, ensure adherence to research protocols, Good Clinical Practices (GCP), IRB, FDA and other applicable federal, state or local regulations. Assist in the timely preparation and maintenance of compliance and regulatory documents from the initial submission through study closure.
â— Oversee regulatory conditions of studies
â— Assist with development of clinical research protocol documentation
â— Report findings and adverse events as applicable |
