Research Nurse Specialist III

Research Nurse Specialist III - 1701107


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 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

Preferred Skills and Experiences:

• Clinical research experience preferred but not required
• Knowledge with cancer patient population
• Experience with Excel, Word, and Star Panel preferred
• Experience working in a collaborative environment
• Strong leadership skills
• Strong written and oral communication
• Team Player

Additional Information:
This is a part time, hourly position requiring 20 hours per week. Hours will vary between 8am-5pm Monday through Friday.

Basic Qualifications

Job requires Graduate of an approved discipline specific program and 5 years of experience or the equivalent.

Licensure, Certification, and/or Registration (LCR):

Registered Nurse