University of Florida College of Medicine - Jacksonville · 8 hours ago
Clinical Research Coordinator III
Metro Jacksonville
Full-time
Onsite
Mid Level
$70K/yr - $80K/yr
3+ years expUniversity of Florida College of Medicine - Jacksonville is seeking a Clinical Research Coordinator III. The role involves conducting quality assurance reviews and ensuring compliance with clinical research documentation, as well as managing electronic regulatory systems and liaising with institutional offices.
Higher Education
Responsibilities
Conduct periodic quality assurance reviews of clinical research documentation, including source data, case report forms, and regulatory files, to ensure GCP and institutional compliance
Identify findings, develop corrective and preventive action (CAPA) plans, and track resolution through completion
Support readiness for sponsor, federal, and internal audits by maintaining accurate and complete research documentation
Develop and deliver QA tools, checklists, and training resources for study teams and faculty
Ensure data integrity and standardization across protocols, coordinating with research finance, compliance, and departmental teams
Generate OnCore reports to support leadership oversight and operational decision-making
Oversee the maintenance of electronic regulatory binders in Veeva eRegulatory to ensure complete, accurate, and compliant documentation
Conduct regular quality control checks of study regulatory files and assist in resolving discrepancies
Support and train faculty and staff in the use of Veeva for document submission, routing, and approval workflows
Liaise between the study team, IRB, and other institutional offices to ensure timely and compliant submissions
Maintain awareness of current institutional, federal, and sponsor regulations impacting human subjects research
Qualification
Required
Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience
Demonstrated experience using CTMS, eRegulatory, and electronic IRB submission systems
Strong knowledge of ICH-GCP, FDA, OHRP, and institutional research regulations and standards
High attention to detail and strong organizational skills
Excellent interpersonal, written, and verbal communication abilities
Ability to manage multiple priorities and meet deadlines in a complex academic environment
Proven ability to work collaboratively across departments and disciplines
Proficiency with Microsoft Office Suite and research management applications
Preferred
Master's degree or an allied health professional degree in an appropriate area and 5 years of experience coordinating or managing clinical research in an academic medical center or hospital-based environment, preference for experience in performing quality assurance reviews on clinical trial adherence
Company
University of Florida College of Medicine - Jacksonville
The University of Florida College of Medicine - Jacksonville is a regional campus of the University of Florida comprised of more than 400 UF faculty physicians, 360 resident and fellow physicians, 50 third- and fourth-year medical students and 34 ACGME-accredited residency and fellowship programs.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
CDA Foundation
2024-03-18Grant
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