NashvilleTNRecruiter Since 2001
the smart solution for Nashville jobs

Research Nurse Specialist II, Vaccine Research

Company: Drug Information Association Inc
Location: Nashville
Posted on: June 12, 2021

Job Description:

Description

Research Specialist II, Vaccine Research

JOB SUMMARY:

Assures the integrity and quality of clinical research trials are maintained under occasional guidance. Plans and implements recruitment procedures, manages enrollment of the trial, and ensures compliance with protocols.

Key Responsibilities

  • 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 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
  • 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, 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
  • 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

Department/Unit Summary:

The Vanderbilt Vaccine Research Program was formed in 2001 to conduct clinical and translational research in vaccines, vaccine preventable diseases, and pediatric infectious diseases. Led since 2014 by Dr. Buddy Creech, Associate Professor of Pediatric Infectious Diseases, the mission of the VVRP is to reduce the burden of infectious diseases worldwide through the discovery, evaluation, and delivery of effective and safe vaccines and therapeutics.

Our vision is that tomorrow will be better than today .

Position Shift:

  • First Shift

View how Vanderbilt Health employees celebrate the difference they make every day:

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.

Our Nursing Philosophy:

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.

Achieve the Remarkable:

Learn more about VUMC Nursing:

VUMC Nursing : http://www.mc.vanderbilt.edu/root/vumc.php?site=vanderbilt-nursing

Keywords: Drug Information Association Inc, Nashville , Research Nurse Specialist II, Vaccine Research, Other , Nashville, Tennessee

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest Tennessee jobs by following @recnetTN on Twitter!

Nashville RSS job feeds