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 :
The Center for Clinical and Translational Research (CCTR) in the Department of Pediatrics provides support for the Department's clinical research enterprise. Focus areas are improvements in clinical research facilities, support for Division's clinical trials activities, to support IRB, contracting, budgeting and other activities related to clinical trials, perform internal study audits, serve as a liaison to the Vanderbilt Coordinating Center, the Clinical Research Center, the Clinical Trials Center, and as an informational and educational clearing house to keep research faculty and staff apprised of the latest developments in clinical research both from external sponsors as we well as within the VUMC.
Under the guidance and supervision of the Director of the CCTR (PI), the Research Nurse Specialist III (RNS III) is responsible for supporting the Director's efforts to improve and expasnd clinical research infrastructure and expertise within the Department. For specific clinical trials, the Research Nurse Specialist III with work with individual Departmental PIs assuring that the integrity and quality of the clinical research studies are maintained and are conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines and Vanderbilt Policy and Procedure. The RNS III independently plans and implements recruitment procedures for potential participants, manages enrollment of the trial from screening to randomization to study completion, evaluates clinical data, ensures compliance with protocols and overall clinical objectives, serves as a resource for inquiries on study projects, manages study-related procedures as required by the protocol and maintains communication with the sponsor, IRB, DSMB and other research related entities. Specific responsibilities also include subject recruitment and informed consent, both in person and by telephone, phlebotomy and sample processing and storage, data entry, and coordination of multicenter studies. This position offers the opportunity to provide leadership as part of a dynamic and growing team.
1. Knowledge, understanding, and implementation of policies, procedures, and regulations governing human subject research.
· Knowledge and understanding of the Vanderbilt policies and regulations governing the protection of human subjects, as well as maintains a clear understanding of the Federal regulations governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH guidelines, and HiPAA regulations
· Maintains working knowledge of the operations of the Vanderbilt Institutional Review Board
· 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. Assists in budget and contract negotiation and facilitates interactions between sponsors and institutional departments.
2. Knowledge, understanding, implementation, and management of clinical trial operations
· Understands, implements, and follows a clinical study protocol and is able to conduct studies independently, including accurate data collection and record keeping for all aspects of the study.
· Ability to multi-task, managing multiple assignments while maintaining documentation and study visits and procedures in a timely manner.
· Utilizes nursing skills to complete all research protocols, including patient recruitment, screening, eligibility, informed consent, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication dispensing and other protocol specific investigational procedures. Utilizes nursing skills and processes to identify participant and study problems, and utilizes problem-solving skills to identify and implement solutions.
· Provides education and training to appropriate personnel and participants in research specific methodology and procedures
· Proactively involved in quality improvement through ongoing assessment and through the identification of issues and planning and evaluation of quality improvement
· Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research 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.
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 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 clearly understand what is expected of and from them in the course of participating in a clinical trial
· Encourages open communication with participants by providing them with contact information and being available to answer their calls
· Performs procedures for research only as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk. Reports all deviations to the Principal Investigator and/or senior personnel who will determine of a protocol amendment or other safety assessments are required
· 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, etc.) as required by protocol, policies and procedures and regulations
4. Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance own professional development. Pursues avenues to ensure awareness of the latest information available to nurses conducting clinical research; examples are provided below
· 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 and participates in CRSC activities
· 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
Graduate of an approved discipline specific program (or equivalent experience) and 5 years experience
Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments:
· US News & World Report: #1 Hospital in Tennessee, #1 Health Care Provider in Nashville, #1 Audiology ( Bill Wilkerson Center ), 12 adult and 10 pediatric clinical specialties ranked among the nation's best, #15 Education and Training
· Truven Health Analytics: among the top 50 cardiovascular hospitals in the U.S.
· Becker's Hospital Review: one of the "100 Greatest Hospitals in America"
· The Leapfrog Group: grade "A" in Hospital Safety Score
· National Institutes of Health: among the top 10 grant awardees for medical research in the US
· Magnet Recognition Program: Vanderbilt nurses are the only group honored in Tennessee
· Nashville Business Journal: Middle Tennessee's healthiest employer
· American Hospital Association: among the 100 "Most Wired" medical systems in the US
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.