Research Nurse Specialist II

JOB SUMMARY:

The Critical Illness, Brain Dysfunction and Survivorship (CIBS) Center is composed of an interprofessional group of physicians, nurses, psychologists, biostatisticians, epidemiologists, pharmacists, physical and occupational therapists and numerous different sources of trainees.
The center's team members work with patients who are, or have been, critically ill and who have suffered from delirium and are at risk for long-term cognitive, functional and neuropsychological impairments.

Under the guidance and supervision of the Principal Investigator, the Research Nurse Specialist II (RNSII) 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 II plans and implements recruitment procedures for potential participants, manages enrollment of the trial from screening to randomization to study completion, ensures compliance with protocols and overall research and clinical objectives, manages study-related procedures as required by the protocol, maintains accurate and timely documentation and maintains communication with the sponsor.

This position is not eligible for visa sponsorship.

The $10,000 sign on bonus is available for full-time research nurse positions. This sign on bonus is not applicable to current VUMC staff or former staff who have worked for VUMC within one year.

KEY RESPONSIBILITIES:

• Knowledge and understanding of policies, procedures, and regulations governing human subject's research incorporates them in the conduct of research and care of participants.
• 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 assures 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 the determination of eligibility and recruitment of 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 accurately and efficiently.
• 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
• 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
• 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

Department Summary:
The Division of Allergy, Pulmonary and Critical Care is directed by Dr. Timothy Blackwell and its mission is to:

• deliver world-class clinical care to patients with allergic diseases, pulmonary conditions, and critical illness through employing a collaborative, multi-disciplinary approach with a wide range of clinical programs.
• lead in the development of cutting-edge, patient-focused research that extends from basic discoveries to clinical implementation.
• provide state-of-the-art education and training including a strong fellowship program to inspire and nurture the next generation of leaders in allergy and immunology, pulmonary medicine, and critical care.

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Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. It is a place where your diversity -- of culture, thinking, learning and leading -- is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt's mission is to advance health and wellness through preeminent programs in patient care, education, and research.

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We believe highly skilled and specialized nursing care is essential to Vanderbilt University Medical Center's mission of quality in patient care, education and research. We believe nursing is an applied art and science focused on helping people, families and communities reach excellent health and well-being.

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* Education & Professional Development: http://www.vumcnursingcareers.com/professional-development.html

* Life In Nashville: http://www.vumcnursingcareers.com/nashville.html

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