Clinical Research Nurse-Department of Neurosurgery-Comprehensive Spine Center

Classification Title:

Clinical Research Nurse

Classification Minimum Requirements: Graduate of a nationally accredited nursing program and four years of professional nursing experience. Licensed as a registered nurse in accordance with Chapter 464, Florida Statutes. Job Description:

Coordinate assigned clinical research trials and projects in spine care within clinic and surgical settings:
• Serve as a contact and liaison between medical staff, nursing staff, and other university and hospital departments as well as the sponsor (when applicable).
• Maintain SOPs (standard operating procedures) and other clinical research-related documents for the research team.
• Train and continually educate clinical research team, medical staff, nursing staff, and affiliates on protocols and protocol compliance.
• Educate staff on trial eligibility requirements and actively encourage trial enrollment within the Comprehensive Spine Program.
• Distribute sponsor literature to assist staff in maintaining patient eligibility and provide contact resources for study investigators and research team.
• Coordinate with investigational pharmacy for storage, randomization, and distribution of medications for assigned protocols.
• Coordinate space, equipment, supplies, resources, and expertise needed in clinic and surgical settings to support the clinical research trials.
• Prepare IRB reports and documentation and communicate deadlines to the Principal Investigator (PI) and research team.
• Assist in development and implementation of quality assurance checks for clinical trials
• Administer, collect, and record patient and family-related questionnaires, tests, surveys, and other research materials and correspondence.
• Ensure adherence to study protocols

Provide education and nursing care in support of spine-related clinical research trials and projects in clinic and surgical settings:
• Act as a liaison between the clinical research team, spine surgery research office, patients, families, outside agencies, and the public.
• Educate and support prospective and existing patients and families about spine-related clinical trials and research initiatives.
• Actively screen prospective and current patients for eligibility.
• Obtain informed consent after verifying eligibility.
• Order necessary tests, equipment, and medications in alignment with protocol.
• Collect body fluid specimens for processing and shipping, as needed.
• Educate patients and/or families about medical and surgical components of the clinical-research trials.
• Under attending supervision, direct patients to necessary medical care and notify appropriate clinical personnel and investigators.
• Review lab and test results and communicate abnormalities to investigators and care teams.

Provide administrative and regulatory support for assigned spine-related clinical research trials:
• Maintain HIPAA-compliant records of research trials, including detailed data collection.
• Record and maintain case report forms (CRFs) and source documentation.
• Notify PIs of any Adverse Events (AEs) or Serious Adverse Events (SAEs) for timely IRB and sponsor reporting.

• Assist with regulatory management for FDA documentation, including Investigational New Drug (IND) studies when applicable.
• Provide weekly screening and patient progress reports to clinical research coordinators or designated staff.
• Assist with preparation of reports for funding sources, regulators, investigators, and the research office.
• Support on-site monitoring visits and ensure protocol adherence.
• Complete IRB reports and paperwork, ensuring regulatory compliance.
• Support billing, IRB, and administrative responsibilities as needed.
• Develop and implement quality assurance protocols for spine clinical trials.

Project Management of Complex Multi-site Clinical Trial Activities:
• Conduct site initiation, monitoring, and close-out visits per study requirements and regulatory standards.
• Evaluate site compliance with protocols, human subject protections, informed consent processes, and data integrity.
• Maintain collaborative relationships with investigators and site staff.
• Assess site readiness, including staffing and facilities, for study execution.
• Train and support designated personnel on protocol adherence and regulatory standards.
• Proactively identify and assist in resolving site-specific challenges including recruitment and data quality issues.
• Generate and resolve data queries and communicate findings to trial supervisor.
• Assist in developing study-specific databases and documents.
• Create and deliver site-training materials.

Expected Salary:

$81,100-$92,200

Required Qualifications: Gradu