Research Nurse Specialist II (Pediatric Endocrinology)
Discover Vanderbilt University Medical Center:
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.
Monroe Carell Jr. Children's Hospital at Vanderbilt is one of the nation's leading children's hospitals. We treat and help prevent all health issues ranging from colds and broken bones to heart disease and cancer.
The world-class facilities at Children's Hospital are a testament to our community's dedication to the health of children. Constructed in 2004 and expanded in 2012, our 271-bed hospital is a child-friendly place built on the science of healing.
A building alone does not make a great hospital. Our exceptional medical teams and the generous support of people like you enable us to provide every child who comes to us with the hope of improved health. Children's Hospital is a nonprofit facility. No child who needs our services is denied care on the basis of limited ability to pay.
Many of our doctors and surgeons are nationally recognized researchers who are finding new ways to cure and prevent childhood diseases. Their work preventing and treating premature birth, cancer, heart disease, spina bifida, and many other conditions is an investment in the future. We are at an important crossroads in child health. Our commitment to research and advocacy positions us to bring the promise of good health to children and families in our community and to share that hope with the world.
Your Role :
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)
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 th...e 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.