Description Vanderbilt University School of Nursing is accepting applications for our Research Nurse Specialist III – Research Grants position. In this role, you will be part of a dynamic team of professions that conducts clinical trials involving the oncology patient population. Under the guidance and supervision of the Principal Investigator, the Research Nurse Specialist III (RNS III) is responsible for assuring that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines and Vanderbilt Policy and Procedure. The RNS III independently plans and implements recruitment procedures for potential participants, manages enrollment of the trial from screening to randomization to study completion, evaluates clinical data, ensures compliance with protocols and overall clinical objectives, serves as a resource for inquiries on study projects, manages study-related procedures as required by the protocol and maintains communication with the sponsor, IRB, DSMB and other research related entities. Key Functions and Expected Performances: Knowledge and understanding of policies, procedures, and regulations governing human subject's research incorporates them in the conduct of research and care of participants. Proficiently prepares and processes new research proposals, amendments, continuing review applications, adverse events, budgets, and D&H accounts according to institutional and departmental policies and procedures and federal regulations. Knowledge and understanding of the Vanderbilt policies and regulations governing the protection of human subjects Has a working knowledge of the operations of the Vanderbilt Institutional Review Board and its requirements for the protection of human subjects Maintains a clear understanding of the Federal regulations governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH guidelines, and HiPAA regulations Knowledge and understanding of the management and implementation of clinical trial operations Understands, implements and follows a clinical study protocol and is able to conduct multiple studies independently, including accurate data collection (able to identify when training is needed to safely and accurately perform or assess required procedures. Problem solves when needed to acquire or deliver such training). Independently prepares and stores critical documents required to be maintained and provided to the sponsor during and after the conduct of a clinical trial Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures Participates in the determination of eligibility and recruits candidates for study participation. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation in an accurate and timely manner. Provides education and training to appropriate personnel and participants in research specific methodology and procedures Maintains open and positive communications with investigators, participants, co-workers, other departments and sponsors. Collaborates with other departments to seek solutions to global research concerns. Ability to multi-task, managing multiple assignments while maintaining documentation and study visits and procedures in a timely manner. Digests complex clinical information to determine if documentation is accurate, complete, and to ensure procedures contain appropriate safeguards. Understands standard of care versus research and continually assesses need for additional protections for the protection of research participants and the appropriateness of research data. Utilizes nursing skills and processes to identify participant and study problems, and utilizes problem solving skills to identify solutions following through
Vanderbilt University is a center for scholarly research, informed and creative teaching, and service to the community and society at large. Vanderbilt will uphold the highest standards and be a leader in the quest for new knowledge through scholarship, the dissemination of knowledge through teaching and outreach, and the creative experimentation of ideas and concepts. In pursuit of these goals, ...Vanderbilt values most highly intellectual freedom that supports open inquiry, equality, compassion, and excellence in all endeavors.