Research Nurse Specialist II Pediatric Delirium Research Program
Location: Nashville, Tennessee
Academic / Research
Internal Number: 2103211
Research Nurse Specialist II, Pediatric Delirium Research Program
Job Summary: 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 Principal 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, 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.
Knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporation of them in the conduct of research and care of participants
Possesses a basic awareness of the Federal regulations governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations
Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications and adverse events according to institutional and departmental policies and procedures and federal regulations
Possesses a basic awareness of the Vanderbilt policies and regulations governing the protection of human subjects
Knowledge and understanding of the management and implementation of clinical trial operations
Understanding and capability to perform the procedures required of each study protocol (obtains training needed to safely and accurately perform or assess required procedures)
Prepares and stores critical documents required to be maintained and provided to the sponsor prior to, during and after the conduct of a clinical trial
Performs packaging and ships study medication and specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with IATA and sponsor shipping guidelines
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. Troubleshoots trial recruitment strategies to ensure trials are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation.
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.
Digests complex clinical information to determine if documentation is accurate, complete, and to ensure procedures contain appropriate safeguards. Ability to multi-task, managing multiple assignments while maintaining documentation and study visits and procedures in a timely manner.
Understands standard of care versus research and continually assesses need for additional protections for the protection of research participants and the accuracy and 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 improvements.
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 the 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
Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them in the course of participating in a clinical trial
Utilizes nursing skills to complete 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
Performs procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and reports all deviations from the protocol 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, telephone follow-up interviews and research data
Utilizes knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to the principal investigator and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations
Conducts literature searches and assesses new information as appropriate regarding 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 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 monthly meetings
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 10 hours of educational activities annually or pursuing an advanced academic education or certifications
Develops and achieves personal and professional goals
Participates in and maintains professional certifications, licensure and credentialing as required of nurses employed at Vanderbilt (i.e., CPR certification)
Further knowledge base by completing series Basic of Conducting Clinical Research 102 or equivalent within the first year.
Department/Unit Summary: 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.
Position Shift: Day Shift. This position also includes some weekends.
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