Clinical Research Coordinator I-Department of Neurosurgery (Spine)

Spine•Gainesville, FL

16h

About The Position

This position supports the conduct of clinical research studies and clinical trials within the Department of Neurosurgery (Spine). The role involves ensuring compliance with approved protocols, Good Clinical Practice (GCP), institutional policies, and applicable regulatory requirements. Key responsibilities include participant screening, recruitment, enrollment, and the informed consent process. The coordinator will manage protocol-related study visits, procedures, and participant follow-up, including scheduling and maintaining accurate records. Data collection, entry into various systems (CRFs, EDC), and assisting with data query resolution are crucial. The role also involves specimen collection and processing, participant safety monitoring (adverse events, deviations), and supporting monitoring visits, audits, and regulatory submissions to the IRB. Additionally, the position will assist with study registration on ClinicalTrials.gov, record retention, and promoting ethical research conduct. A significant part of the role focuses on collecting and managing clinical outcomes data, particularly patient-reported outcome measures (PROMs) for the Spine Program, including tracking, outreach for completion, and maintaining outcomes databases. The coordinator will also generate reports, support data collection tools, and collaborate with clinical and research staff. Administrative support for the Spine Research Program leadership and staff includes coordinating meetings, preparing materials, assisting with reports and presentations, managing study files, and supporting financial tracking and operational activities. Support for students, volunteers, and observers may also be required.

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.