Research Nurse Specialst III, Vaccine Research Program

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
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 to implement solutions and assuring goals are met.
Proactively involved in quality improvement through ongoing assessment and through the identification of issues and planning and evaluation of quality improvement
Assists in budget and contract negotiation and facilitates interactions between sponsors and institutional departments.
Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and public responsible for, or concerned about, protections for human participants of research
Assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical trials
Utilizes nursing skills to complete all research protocols, including patient recruitment, screening, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication dispensing and other protocol specific investigational procedures
Independently uses and documents the nursing process to plan, deliver and evaluate goal focused, individualized, safe, age-specific care as it relates to uncomplicated research participants and with assistance for complicated research participants
Encourages open communication with participants by providing them with contact information and being available to answer their calls
Participates in the ongoing informed consent process, ensuring that human subjects clearly understand what is expected of and from them in the course of participating in a clinical trial
Performing procedures for research only as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk
Reporting all deviations to the Principal Investigator and/or senior personnel who will determine of a protocol amendment or other safety assessments are required
Maintains accurate records to document recruitment efforts and telephone follow-up interviews
Utilizes knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations
Conducts literature searches as appropriate for new studies and at the time of continuing review to keep up-to-date in the research field of study in order to determine if significant historical or new findings exist that may impact the risk/benefit ratio of the research participant
Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance own professional development. Pursues avenues to ensure awareness of the latest information available to nurses conducting clinical research, for example
Reviews the Research Support Services website to obtain information regarding available and required in-services, required certifications and to obtain important updates
Attends the Clinical Research Staff Council and participates in CRSC activities
Attends in-services advertised by the Institutional Review Board, Research Support Services, professional societies, etc.
Demonstrates initiative in self-directed learning, as evidenced by attendance of professional development opportunities. Actively seeks new learning opportunities. Sees learning as part of work

Assumes responsibility for continuous learning, engaging in a minimum of 15 hours of educational activities annually or pursuing an advanced academic education or certifications