The Research Nurse Specialist II (RNSII) is a key position on the pediatric research team within the Critical Illness, Brain Dysfunction, and Survivorship (CIBS) center, to advance the care of critically ill adults and children. The RNS II will work closely with senior Research Nurse/Coordinators and the Principle Investigators to assure the integrity and quality of studies and that trials are conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines and Vanderbilt Policy and Procedure. This RNS II position will be primarily devoted to the conduct 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). The RNS II will assist in the 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, led 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.
KEY Position Qualifications:
This position requires a graduate of an approved nursing program and one 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.
Although a position may exist for a specified or indefinite period, staff who accept term positions are not guaranteed employment for the entire period; they are employed for indefinite periods within the limit of the appointment. There are no guarantees of continued employment, either within the term or when the term ends.
Knowledge of, or previous experience with the pediatric population including patients on mechanical ventilation in a clinical setting.
Comfort assessing critically ill children in the presence of the treatment team, research team, and/or family members.
Understanding of pediatric milestones and can appropriately communicate with patients on developmentally appropriate levels.
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
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