Mar 25, 2020

Research Nurse Specialist I

  • Vanderbilt Health
  • Nashville, TN, USA

Job Description

Research Nurse Specialist 1 – VICTR - VCC

Requisition #1913510

Graduate of an approved discipline specific program (or equivalent experience) and < 1 year experience



JOB SUMMARY:
Under the guidance and supervision of the Principal Investigator, the Research Nurse Specialist I 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 Research Nurse Specialist I 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.

KEY RESPONSIBILITIES:

  • Conveys a basic knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates 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
  • With assistance, 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
  • Possesses a basic awareness of the operations of the Vanderbilt Institutional Review Board and its requirements for the protection of human subjects (Seeks to attend IRB 101 in-service and completes IRB testing requirements prior to beginning interactions with human subjects)
  • Communicates a basic knowledge and understanding of the management and implementation of clinical trial operations:
  • Exhibits the capability to understand and follow a clinical study protocol
  • Understands and is capable of performing the procedures required of each study protocol (obtains training needed to safely and accurately perform or assess required procedures)
  • With assistance, 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
  • Identifies and procures equipment and supplies needed to fulfill project requirements
  • With direction, records data from source documentation onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and source documentation
  • Performs packaging and ships study medication and specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with IATA and sponsor shipping guidelines
  • With supervision, 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
  • With direction assists with study completion, data lock, study closeout and archiving of study files ensures completeness and continuity of all study data performs ongoing checks of clinical data that has been entered on the case report forms (paper or electronic) to ensure that it is being entered in a timely and accurate manner reviews all study data queries correcting any inaccurate data and flagging questionable data for resolution
  • Collaboratively participates in study team meetings
  • 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
  • With guidance assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical trials
  • Continuously assesses participants to ensure continued eligibility for participation in research
  • 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
  • Encourages open communication with participants by providing them with contact information and being available to answer, address or refer their calls
  • With supervision 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
  • Considers scheduling subject appointments to utilize their and personnel time efficiently
  • 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
  • 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 5 hours of educational activities annually or pursuing an advanced academic education or certifications
  • Participates in and maintains professional certifications, licensure and credentialing as required of nurses employed at Vanderbilt (i.e., CPR certification)
  • Further knowledge base by attending the Basic Research 101 within first three months of employment date
About the Department:

The Vanderbilt Coordinating Center (VCC) provides comprehensive, central support for a diverse platform of clinical and translational research projects. The VCC first began in 1989 under the direct leadership of Dr. Gordon Bernard. Its initial focus was on providing coordinating center support for investigator-initiated trials overseen at Vanderbilt. In 2016, with the addition of several large, innovative clinical trial grants within the Vanderbilt Institute for Clinical and Translational Research (VICTR) and due to an ever-growing need to provide more specialized, flexible support to Vanderbilt investigators, a need surfaced to reinstate the VCC. For more information, please visit https://vcc.vumc.org.

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