Research Nurse Specialist 3

Vanderbilt University Medical Center•Nashville, TN

About The Position

The Research Nurse Specialist 3 independently assures the integrity and quality of clinical research trials. The role plans and implements recruitment procedures, manages trial enrollment, and ensures compliance with study protocols. Within Pediatric Cardiology, the specialist manages a single IRB for two multi-site studies and multiple studies with subaward sites. The position performs protocol-required procedures while distinguishing standard-of-care from research activities, assesses the need for additional participant protections, and supports regulatory compliance. The specialist screens, recruits, and consents participants; assesses eligibility and continued eligibility; reviews medical records and consults with the Principal Investigator to identify candidates; orders protocol-required tests; and collects and enters data into study databases. The role also handles trial administration, including procuring equipment, preparing documentation, and packaging and shipping medications. It provides education and training to research personnel and participants, serves as a protocol resource for coordinators and student workers at subaward sites, and observes for and reports adverse events to the Principal Investigator and regulatory authorities as required. The position uses nursing and scientific knowledge, evidence-based practice, patient assessment and education, care planning, and regulatory expertise. It serves as a resource and coach for less experienced colleagues and contributes to high-quality, safe, and compliant research operations.

Requirements

Current Registered Nurse licensure (LIC-Registered Nurse).
At least 2 years of relevant work experience.
Graduate of an approved discipline-specific program.

Responsibilities

Manage the single IRB for two multi-site studies.
Perform administrative duties for trials, including procuring equipment, preparing documentation, and packaging and shipping medications.
Manage multiple studies with multiple subaward sites.
Perform procedures required by study protocols and distinguish standard-of-care activities from research activities.
Continually assess whether research participants need additional protections.
Screen, recruit, and consent study subjects.
Order tests required by research protocols.
Collect study data and enter it into the appropriate databases.
Identify and recruit eligible candidates and regularly reassess their continued eligibility.
Review medical records and communicate with the Principal Investigator to identify eligible study candidates.
Troubleshoot recruitment strategies to help complete trials in a timely manner.
Educate and train appropriate personnel and participants in research-specific methods and procedures.
Train coordinators and student workers at subaward sites on study protocols and serve as a resource to them.
Observe for and report adverse events to the Principal Investigator and regulatory authorities as required by protocol, policies, procedures, and regulations.
Submit required information to regulatory authorities when adverse events are observed.
Apply evidence-based practice, care planning, patient assessment and education, and regulatory and scientific knowledge in research work.
Support colleagues through coaching, communication, relationship-building, and development of less experienced peers.
Promote quality, safety, continuous improvement, and effective use of organizational resources.