This position will provide varied support for clinical trials and research projects within the Emergency Medicine Research Division. This role will work under the guidance of the principal investigators and the director for research operations as part of the EM Clinical Research Operations team. Responsibilities will include responsible for recruitment and maintenance of patients in clinical trials. Serving as study coordinator, 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 procedures.
Vanderbilt University Medical Center's Department of Emergency Medicine is a national leader in emergency care research. Led by 8 core faculty and an extensive research infrastructure, we are top leaders in designing innovative ED-based research and are top enrollers in both industry and federally funded studies. Our research staff actively screens patients over 100 hours each week in the emergency departments at VUMC and the Tennessee Valley Hospital. Combined, these Eds see over 100,000 patients each year. To ensure timely enrollment in therapeutic studies, the research faculty are immediately available to assist the student team on a daily basis. For more information, please visit https://vanderbiltem.com/em-research.
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* 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.
Key functions and expected performances include but are not limited to the following:
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
1a. Possesses a basic awareness of the Federal regulations governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations
1b. 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
1c. Possesses a basic awareness of the Vanderbilt policies and regulations governing the protection of human subjects
2. Knowledge and understanding of the management and implementation of clinical trial operations
2a. Understanding and capability to perform the procedures required of each study protocol (obtains training needed to safely and accurately perform or assess required procedures)
2b. 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
2c. Performs packaging and ships study medication and specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with IATA and sponsor shipping guidelines
2d. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures
2e. 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.
2f. Provides education and training to appropriate personnel and participants in research specific methodology and procedures
2g. Maintains open and positive communications with investigators, participants, co-workers, other departments and sponsors.
2h. 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.
2i. 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.
2j. 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.
2k. Proactively involved in quality improvement through ongoing assessment and through the identification of issues, and planning and evaluation of quality improvements.
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
3a. Assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical trials
3b. 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
3c. 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
3d. 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
3e. 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
3f. Maintains accurate records to document recruitment efforts, telephone follow-up interviews and research data
3g. 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
3h. 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
4. 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
4a. Reviews the Research Support Services website to obtain information regarding available and required in-services, required certifications and to obtain important updates
4b. Attends the Clinical Research Staff Council monthly meetings
4c. Attends in-services advertised by the Institutional Review Board, Research Support Services, professional societies, etc
4d. 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
4e. Assumes responsibility for continuous learning, engaging in a minimum of 10 hours of educational activities annually or pursuing an advanced academic education or certifications
4f. Develops and achieves personal and professional goals
4g. Participates in and maintains professional certifications, licensure and credentialing as required of nurses employed at Vanderbilt (i.e., CPR certification)
4h. Further knowledge base by completing series "Basic of Conducting Clinical Research 102" or equivalent within the first year.
This is a full-time position; exempt position. Work hours will include variable scheduled shifts and weekend rotations.
Salary is dependent upon education and experience.
Background screens will be performed, and education will be verified prior to employment. Please be prepared to provide required information and/or documentation.
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.