Feb 18, 2020

Research Nurse Specialist II

  • Vanderbilt Health
  • Nashville, TN, USA

Job Description

Research Nurse Specialist IIGI Medicine

Role Summary:

Under the guidance and supervision of the Principal Investigator and GI Clinical Research leadership, the Research Nurse Specialist II (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 trial 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.

  • 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 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, GI clinical research leadership, study 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 as often as possible

  • 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 Summary:

The Division of Gastroenterology and Hepatology supports the GI Clinical Research Enterprise (GICRE), which is a centralized clinical trials office in close proximity to the Vanderbilt Hospital and Clinic. Currently, the office manages and coordinates approximately 200 research projects, comprised of 70% industry-sponsored clinical trials and 30% investigator-initiated studies. The clinical trials enterprise employs experienced research nurses, clinical research coordinators, regulatory and quality assurance staff, and program managers.

The goals of the Gastroenterology Division are to provide outstanding medical care to persons with diseases of the gastrointestinal tract and liver, to train gastroenterology and to perform cutting-edge biomedical research to improve our understanding of digestive diseases. There are three strong goals that define the GI Division. The first component is a strong biomedical research with faculty that is focused on innovative discovery-based research. The second is the education and training of medical students, residents, postdoctoral fellows, GI research and GI Clinical fellows. Third the clinical and endoscopic practice at Vanderbilt is focused on compassionate and outstanding patient care. In addition, the goals of the GI Clinical Research department are to unite innovative leadership with operational expertise to optimize the quality of clinical research and improve health by providing quality services, promoting collaboration and presenting creative solutions.

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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.


VUMC Recent Accomplishments

Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments:

VUMC Recent Accomplishments

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: 6th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.