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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.
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.
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