Clinical Research Coordinator I-Department of Neurosurgery (Spine)

University of Florida • Gainesville, FL

2d • $53,250 - $60,500

About The Position

This position supports the conduct of clinical research studies and clinical trials within the Department of Neurosurgery (Spine), ensuring compliance with approved protocols, Good Clinical Practice (GCP), institutional policies, and applicable regulatory requirements. The role involves screening participants, assisting with recruitment and enrollment, and participating in the informed consent process. Key responsibilities include coordinating study visits, maintaining accurate records, performing data collection and entry, processing laboratory specimens, and supporting participant safety by reporting adverse events. The coordinator will also assist with study monitoring, audits, regulatory submissions to the IRB, and maintaining essential regulatory documents. Additionally, the role serves as a primary coordinator for collecting patient-reported outcome measures (PROMs) and other clinical outcomes data for the Spine Program, managing PROM collection, monitoring completion rates, and maintaining outcomes databases. Administrative support includes coordinating research team meetings, assisting with reports and presentations, managing study files, and supporting financial tracking and operational activities.

Requirements

• Associate's degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.

Nice To Haves

• Experience working in a clinical setting or research setting.
• Familiar with medical terminology.
• Experience with systems, including Epic and OnCore.
• Familiar with GCP (Good Clinical Practice).

Responsibilities

• Support the conduct of clinical research studies and clinical trials in compliance with approved protocols, Good Clinical Practice (GCP), institutional policies, and applicable regulatory requirements.
• Screen potential research participants and assist with patient recruitment and enrollment activities.
• Participate in the informed consent process and assist with educating participants and families regarding study procedures, requirements, interventions, and follow-up activities.
• Coordinate protocol-related study visits, research procedures, and participant follow-up activities.
• Schedule participant visits, testing, and study-related procedures.
• Maintain accurate and complete study source documentation and research records.
• Perform data collection and accurate data entry into study databases, case report forms (CRFs), and electronic data capture systems.
• Assist with the resolution of data queries and routine data quality review activities.
• Collect, process, and ship laboratory specimens as required by study protocols.
• Support participant safety by identifying and reporting adverse events and protocol deviations in accordance with study and institutional requirements.
• Assist with study monitoring visits, audits, site initiation activities, and study closeout procedures.
• Maintain essential regulatory documents and assist with the preparation and submission of regulatory materials to the Institutional Review Board (IRB) and other oversight bodies.
• Assist with study registration and maintenance activities in ClinicalTrials.gov as assigned.
• Retain and archive study records in accordance with institutional and sponsor requirements.
• Participate in promoting Human Subjects Protection and ethical conduct of research activities.
• Serve as a primary coordinator for collection of patient-reported outcome measures (PROMs) and other clinical outcomes data for Spine Program research studies and quality initiatives.
• Administer, track, and manage PROM collection throughout the patient care continuum, including preoperative and postoperative follow-up periods.
• Monitor completion rates and conduct participant outreach to improve data collection and retention.
• Maintain outcomes databases and ensure accuracy, completeness, and integrity of collected data.
• Assist with tracking clinical outcomes and quality metrics for Spine Program research projects and programmatic initiatives.
• Generate routine reports and summaries of study enrollment, follow-up status, and outcomes data.
• Support development and maintenance of data collection tools, dashboards, and reporting processes used for research and quality improvement initiatives.
• Collaborate with clinical staff, providers, and research personnel to facilitate efficient collection and management of outcomes data.
• Support Spine Research Program leadership and research staff with study-related administrative activities and special projects.
• Coordinate research team meetings and assist with preparation of meeting materials and documentation.
• Assist with preparation of reports, presentations, abstracts, manuscripts, and program-related documents.
• Support management of study files, investigator documentation, and research program records.
• Assist with study finance tracking and other operational activities as assigned.
• Provide support for student, volunteer, and observer activities within the research program as appropriate.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree