Clinical Research Analyst I

University of Florida • Jacksonville, FL

3d • $53,000 - $60,000

About The Position

The Clinical Research Office (CRO) in the Office of Research Affairs (ORA),
Dean’s Administration, College of Medicine–Jacksonville, is seeking a Clinical
Research Analyst I to support clinical trial operations and protocol management
within the University of Florida’s Clinical Trials Management System (CTMS).
This position assists with the development, review, and maintenance of clinical
research protocols and related documentation to ensure compliance with
institutional policies, sponsor requirements, and applicable regulatory
standards. The analyst will support the implementation and management of
research workflows within the CTMS while providing quality review and
operational support for research projects conducted across the College of
Medicine–Jacksonville.

This role works collaboratively with investigators, research coordinators,
administrators, and institutional stakeholders to facilitate accurate protocol
setup, billing compliance reviews, and research calendar and budget development.
The Clinical Research Analyst I provides technical support and guidance to study
teams regarding the use of the CTMS and institutional processes, assists with
coverage analysis activities, and supports workflow management to ensure timely
and accurate completion of assigned tasks. The position contributes to
maintaining data integrity, operational efficiency, and regulatory compliance
for the clinical research portfolio within the CRO.

Requirements

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

Nice To Haves

• One year of experience in clinical research administration and/or financial management in an academic/medical setting.
• Familiarity with the OnCore CTMS by Advarra or similar clinical trial management software Ability to balance customer service and research compliance.
• Ability to organize and work effectively, prioritize, be flexible, and stay on task in a high paced, high-volume professional environment.
• Skilled in problem-solving techniques, critical thinking, and creativity Strong time management, organizational, documentation, attention to detail, and task follow-up skills.
• Experience using Microsoft Office Applications.

Responsibilities

• Coverage Analysis Support Assist with protocol coverage analyses within the Clinical Trials Management System (CTMS). Support the completion and review of Medicare Coverage Analyses (MCAs) in collaboration with team members. Review vendor-provided MCAs and assist with validation and completion to ensure alignment with institutional coverage analysis standards. Manage coverage analysis requests in a timely and professional manner.
• Intake and Research Compliance Assessments Complete project intake submission assessments for new clinical research studies. Assist with research billing compliance reviews, and ensure required documentation is complete and accurate Review study-related documents to verify adherence to institutional guidelines and regulatory requirements. Prepare Financial Language Assessments (FLAs) for informed consent forms when applicable.
• Portfolio and CTMS Management Manage assigned protocol portfolio within the CTMS and maintain accurate protocol records. Build and maintain billing grids and manage Office of Clinical Research workflows within the CTMS.
• Serve as a resource for study teams navigating the CTMS and assist with troubleshooting or record corrections. Monitor workflow timelines and ensure tasks are completed in accordance with established procedures.
• Calendar and Budget Development SupportBuild sponsor-paid protocol calendars and budgets within the CTMS application. Coordinate with study teams, fiscal teams, and coverage analysis staff to ensure accuracy and completeness. Submit and respond to vendor queries and perform quality assurance review of calendars and budgets developed through the vendor system. Make edits and updates as necessary throughout the calendar and budget development process.
• Customer Support, Training, and System Support Serve as a liaison between investigators, study teams, administrators, and institutional offices.
• Provide technical assistance and guidance to departmental staff and research personnel on sponsor policies and institutional requirements. Assist with identifying system issues and communicating defects or workflow concerns to CTMS management or vendor representatives. Participate in testing and validation of the CTMS during system upgrades and implementation of new functionality.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1-10 employees