Clinical Research Nurse - Clinical and Translational Science Institute (CTSI)

University of Florida•Gainesville, FL
•$70,000 - $75,000

About The Position

The Clinical and Translational Science Institute (CTSI) is seeking a Clinical Research Nurse to support clinical research activities conducted through the Clinical Research Center (CRC). The nurse conducts clinical assessments and administers protocol-specified interventions, including investigational products, in accordance with research protocols. Activities may take place in the CRC at the Clinical and Translational Research Building (CTRB) and in UF Health hospitals and clinics. The role provides education and nursing care to clinical research participants, coordinates assigned clinical research trials and projects, and provides administrative support. The nurse maintains compliance with Good Clinical Practice guidelines, FDA regulations, research protocols, applicable standard operating procedures, and HIPAA confidentiality standards. This is a time-limited position. A health assessment is required.

Requirements

  • Graduate of a nationally accredited nursing program.
  • Three years of professional nursing experience.
  • Licensed as a registered nurse in accordance with Chapter 464, Florida Statutes.

Nice To Haves

  • Nursing experience in a clinical research setting.
  • ACLS certification.
  • Knowledge of nursing principles, practices, and techniques.
  • Knowledge of basic principles and good clinical practice of clinical research.
  • Skill in the use of nursing equipment and instruments.
  • Ability to collect, collate, analyze, and evaluate data from clinical research studies.
  • Ability to plan, organize, and coordinate work assignments.
  • Ability to work effectively and independently.
  • Ability to communicate effectively, verbally and in writing.
  • Expertise in phlebotomy.

Responsibilities

  • Provide clinical care and education to participants enrolled in clinical trials.
  • Administer protocol-specified interventions, including investigational products, in accordance with research protocols.
  • Initiate ordering of tests, equipment, and medications required by protocol.
  • Perform specialized tasks, including pharmacokinetic sampling, euglycemic clamp procedures, and administration of conscious sedation; assist with invasive procedures such as liver biopsies and bronchoscopies.
  • Collect body fluid specimens, including timed specimens for pharmacokinetic assessments, and process specimens for storage and shipping as required by protocol.
  • Cross-train and support the CRC specimen processing laboratory, including specimen receipt, processing, storage, documentation, and shipment in accordance with protocols and applicable SOPs.
  • Assist the principal investigator by planning and conducting the nursing portion of research protocols.
  • Maintain compliance with Good Clinical Practice guidelines and FDA regulations; coordinate research data collection and create data collection tools using applications such as REDCap.
  • Explain research protocols to participants, respond to protocol-related inquiries, schedule participation, and ensure participant compliance with protocols.
  • Act as liaison among research subjects, investigators, the IRB, sponsors, and healthcare professionals.
  • Provide administrative support for NIH’s WEBCamp scheduling and data tracking system.
  • Assist with implementation of the OnCore Clinical Trials Management system.
  • Maintain detailed trial and project records, including data collection, while protecting patient confidentiality in accordance with HIPAA.
  • Alert principal investigators to adverse events and serious adverse events for timely IRB reporting when appropriate.
  • Participate in quality improvement projects and in the development, review, updating, and implementation of CRC SOPs.
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