The Research Nurse Specialist III (RNSIII) is a key position on the Pediatric Delirium Research team, working under the guidance of the Principal Investigator and within the Critical Illness, Brain Dysfunction, and Survivorship (CIBS) center, to advance the care of critically ill children. The RNS III will assume responsibility for assuring the integrity and quality of the pediatric clinical research trial, Maximizing Efficacy of Goal-Directed Sedation to Reduce Neurological Dysfunction in Mechanically Ventilated Infants and Children STUDY (mini-MENDS), 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 will collaborate with the PI and CIBS team to develop recruitment and retention procedures for potential participants, implement and manage recruitment procedures from screening, enrollment, and randomization, to execution of and compliance to the clinical study protocol including overseeing drug titration and clinical/laboratory data collection and recording, performing independent clinical assessments for delirium, serve as an educator of study procedures and a resource for inquiries on study projects, and maintain communication with the sponsor, IRB, DSMB and other research related entities.
The Pediatric Research Group is a consortium of pediatric nurses, advanced practice nurses, pharmacists, intensivists, psychologists, psychiatrists, and anesthesiologists, lead by Dr. Heidi Smith, Associate Professor of Pediatrics and Anesthesiology, and who are united in optimizing cognitive, neuropsychiatric, and functional recovery of critically ill infants and children. The Pediatric Research Group is teamed with the CIBS center where the forefront of discovery and innovation is used to improve lives of people affected by critical illness. The CIBS center team mission is to advance knowledge, education, and models of care for people affected by critical illness.
Position Shift: Day Shift
KEY Position Qualifications: This position requires a graduate of an approved nursing program and five year of experience. Candidates with bachelor's degree and research experience are preferred. Experience in pediatrics and/or pediatric critical care is strongly preferred. Active Tennessee RN license is required.
Additional Information: Salary is dependent upon education and experience. Background screens will be performed, and education will be verified prior to employment. Please be prepared to provide required information and/or documentation.
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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,
We believe nursing is an applied art and science focused on helping people, families and communities reach excellent health and well-being.
Vanderbilt University Medical Center is home to Vanderbilt University Hospital, The Monroe Carell Jr. Children’s Hospital at Vanderbilt, the Vanderbilt Psychiatric Hospital and the Vanderbilt Stallworth Rehabilitation Hospital. These hospitals experienced more than 61,000 inpatient admissions during fiscal year 2015. Vanderbilt’s adult and pediatric clinics treated nearly 2 million patients during this same period. Vanderbilt University Hospital and the Monroe Carell Jr. Children’s Hospital at Vanderbilt are recognized again this year by U.S. News & World Report’s Best Hospitals as among the nation’s best with 18 nationally ranked specialties. Vanderbilt University Medical Center is world renowned because of the innovation, work ethic and collegiality of its employees. From our health care advances to our compassionate care, Vanderbilt owes its accomplishments and reputation to staff and faculty who bring skill and drive and innovation to the medical center day after day. World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.As t...he largest employer in middle Tennessee, we welcome those who are interested in ongoing development in a caring, culturally sensitive and professional atmosphere. Most of us spend so much of our lives at work, we want to be part of maintaining a workplace in which people support one another and encourage reaching for excellence. Many high-achieving employees stay at Vanderbilt because of the professional growth they experience and because of their appreciation of Vanderbilt’s benefits, public events and discussions, athletic opportunities, beautiful setting and, above all, sense of community and purpose.Vanderbilt and its employees share a set of mutual expectations that have been created with productivity, legality, fairness and safety always in mind. We believe that our investment in training and compensating employees multiplies in value when we enable individuals to deliver their best performance for the benefit of us all.