* Oversee Vaccine Trials, especially for young children and immunocompromised hosts
* Knowledge and understanding of the management and implementation of clinical trial operations
* Capability to understand, implement, and follow a clinical study protocol and is able to conduct multiple studies independently (able to identify when training is needed to safely and accurately perform or assess required procedures. Problem solves when needed to acquire or deliver such training).
* Participates in the determination of eligible 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.
* 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.
* 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
* 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 reporting all deviations to the Principal Investigator who will determine of a protocol amendment or other safety assessments are required
* Independently uses and documents the nursing process to plan, deliver and evaluate goal focused, individualized, safe, age-specific care as it relates to uncomplicated and complicated research participants, seeking assistance when needed
* Participates in and maintains professional certifications, licensure and credentialing as required of nurses employed at Vanderbilt (i.e., CPR certification)
The VanderbiltPediatric Infectious Disease Our team is continually at the forefront of research in new and innovative approaches to the diagnosis, treatment and prevention of pediatric infections. With a multi-million dollar research funding program, our faculty, staff, and students are daily committed to fundamental and clinical discovery to benefit the health of children. The diversity of our research is impressive in scope, spanning from studies of the molecular basis of bacterial and viral infections and antimicrobial discovery, to antibiotic surveillance, vaccine trials, emerging infections countermeasures, and outcomes of treatments in South America and Africa. Our faculty direct and/or have appointments in the Institute for Global Health , the Vanderbilt Vaccine Center , the Vanderbilt Vaccine Research Program , and the Vanderbilt Institute for Infection, Immunity and Inflammation.
* Day Shift/ Exempt Position
Click here to view how Vanderbilt Health employees celebrate the difference they make every day:
We believe highly skilled and specialized nursing care is essential to Vanderbilt University Medical Center's mission of quality in patient care, education and research. We believe nursing is an applied art and science focused on helping people, families and communities reach excellent health and well-being.
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 Adult Hospital in Tennessee and metropolitan Nashville, named to the Best Hospitals Honor Roll of the top 20 adult hospitals, 10 nationally ranked adult specialty programs, with 3 specialties rated in the top 10 nationally, Monroe Carell Jr. Children's Hospital at Vanderbilt named as one of the Best Children's Hospital in the nation, with 10 out of 10 pediatric specialties nationally ranked.
* Healthcare's Most Wired: Among the nation's 100 "most-wired" hospitals and health systems for its efforts in innovative medical technology.
* Becker's Hospital Review: named as one of the "100 Great Hospitals in America", in the roster of 100 Hospitals and Health Systems with Great Oncology Programs and to its list of the 100 Hospitals with Great Heart Programs.
* The Leapfrog Group: One of only 10 children's hospitals in the to be named at Leapfrog Top Hospital.
* American Association for the Advancement of Science: The School of Medicine has 112 elected fellows
* Magnet Recognition Program: Received our third consecutive Magnet designations.
* National Academy of Medicine: 22 members, elected by their peers in recognition of outstanding achievement
* Human Rights Campaign Healthcare Equality Index: 6 th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.
Additional Key Elements/ Responsibilities:
Project and Regulator Management
* Knowledge and understanding of policies, procedures, and regulations governing human subject's research. Proficiently 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
* Has expert knowledge and understanding of the Vanderbilt policies and regulations governing the protection of human subjects
* Functions as a departmental resource regarding clinical trials operations e.g., 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
* Independently prepares and maintains critical documents required to be maintained and provided to the sponsor during and after the conduct of a clinical trial. Assists with study completion, data lock, study closeout and archiving of study files.
* Collaboratively directs and participates in study team meetings
* 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.
* Assists in budget and contract negotiation and facilitates interactions between sponsors and institutional departments.
* Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, representatives of professional organizations, participant advocates, and members of the public responsible for, or concerned about, protections for human participants of research
* 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
* Utilizes knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to the principal investigator, DSMB and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations
Training and Employee Oversight
* Proactively involved in quality improvement through ongoing assessment and through the identification of issues and planning and evaluation of quality improvement.
* 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, for example
* Serves as a role model, mentor, supervisor and consultant across teams and departments to provide expertise and share knowledge
* Assists with orientation of new research staff by serving as an available resource, presenting at educational sessions, guiding new staff to attend useful educational sessions, e.g., IRB updates
* Develops tools to assist new and junior staff and keeps information current according to changing research requirements
* Creates an environment that encourages and supports self-development and learning through regular, immediate feedback
* Assures the development of staff members through orientation, training programs and work experience. Strives to develop individualized professional development plan to guide staff to success, focusing on areas needing growth
* Exhibits strong leadership skills. Applies key concepts of facilitative leadership. Assigns and reviews work; effectively prioritizes tasks and work assignments. Delegates tasks as appropriate and follows up to assure completion. Plans, organizes, and completes projects in an efficient manner
* Conducts literature searches as appropriate for new studies and at the time of continuing review. Literature searches are helpful 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
* Reviews the Research Support Services website to obtain information regarding available and required in-services, required certifications and to obtain important updates. Helps provide updates and ideas to RSS group for inclusion on their website. Willing to share tools, forms, and techniques with others
* 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 20 hours of educational activities annually or pursuing an advanced academic education or certifications
* Actively participates in publishing opportunities
* Develops and achieves personal and professional goals
Master's Degree (or equivalent experience) and < 1 year experience. 12 months of nursing experience preferred; Inpatient acute care advanced practice nursing experience desirable.
Registered Nurse License Required
Internal Number: 2007823
About Vanderbilt Health
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.