The Pediatric Endocrinology Research Program is seeking a Research Nurse Specialist II with at least one year of nursing experience to join the Pediatric Endocrinology clinical research team. We are currently experiencing rapid growth in our research program as our Principal Investigators are quickly becoming renowned as key thought leaders in specialty areas of pediatric endocrinology. Our current clinical research discovery is focused on rare and ultra-rare endocrine diseases in children and their families, such as obesity due to Prader-Willi syndrome, hypothalamic obesity, X-linked hypophosphatemic rickets, hypophosphatasia, and osteogenesis imperfecta. This position is ideal for a nurse seeking to develop clinical research skills. Experienced research nurses are also encouraged to apply. Mentoring will be provided by the Principal Investigators and the Research Projects Manager. This highly collaborative research program promotes meaningful contributions in the development of new evidence for life-changing care for our patients and their families, as well as others across the country who seek out our research care. The Research Nurse Specialist in Pediatric Endocrinology can expect to play a key role as we build a dynamic team with expertise in pediatric endocrinology clinical research and work together to make a great impact upon those living with these rare and ultra-rare diseases.
Under the guidance and supervision of the Principal Investigator, the RNS II 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 trail 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.
Key Function #1: 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.
Key Function #2: 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.
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.
Key Function #3: 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
Participants 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 if 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 require 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 ration of the research participant.
Key Function #4: Actively identifies and participates in training, education, and development activities to improve one's 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 a part of the work
Assumes responsibility for continuous learning, engaging in a minimum of 10 hours of educational activities annually or pursuing and advanced academic education or certifications
Participates in and maintains professional certifications, licensure and credentialing as required of nurses employed at VUMC (i.e., CPR certification)
Further knowledge base by completing the series "Basic of Conducting Clinical Research 102" or equivalent within the first year
**Minimum Qualifications Required**
Graduate of an approved discipline specific program (or equivalent experience) and 1 year experience
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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.