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

University of Florida•Gainesville, FL

2d•Onsite

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, located in the Clinical and Translational Research Building (CTRB), and in UF Health hospitals and clinics. The role provides education and nursing care for participants in clinical research trials and projects. It includes coordinating the nursing portion of research protocols, collecting and processing clinical research data and specimens, supporting CRC laboratory operations, and providing administrative support for assigned trials. The nurse maintains compliance with Good Clinical Practice, FDA regulations, HIPAA requirements, and applicable research protocols and standard operating procedures. 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 using 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, both verbally and in writing.
Expertise in phlebotomy.

Responsibilities

Provide clinical care and education to participants enrolled in clinical research trials and projects.
Administer protocol-specified interventions, including investigational products, in accordance with research protocols.
Initiate orders for tests, equipment, and medications required by research protocols.
Perform specialized tasks such as pharmacokinetic sampling, euglycemic clamp procedures, and 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 CRC specimen processing laboratory activities, including specimen receipt, processing, storage, documentation, and shipment in accordance with protocols and SOPs.
Assist principal investigators in planning and conducting the nursing portion of research protocols.
Maintain compliance with Good Clinical Practice guidelines and FDA regulations for research activities.
Coordinate research data collection and create data collection tools using applications such as REDCap.
Explain research protocols to participants, respond to inquiries, schedule participation, and ensure compliance with research protocols.
Act as a liaison among research subjects, investigators, the IRB, sponsors, and healthcare professionals.
Provide administrative support to NIH’s WEBCamp scheduling and data-tracking system.
Assist with implementation of the OnCore Clinical Trials Management system.
Maintain detailed clinical research trial and project records, including data collection, while observing HIPAA patient-confidentiality standards.
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, update, and implementation of CRC standard operating procedures.