Clinical Research Analyst I
About The Position
The Clinical Research Analyst I supports clinical trial operations and protocol management within the University of Florida’s Clinical Trials Management System (CTMS). The position assists with developing, reviewing, and maintaining clinical research protocols and related documentation to support compliance with institutional policies, sponsor requirements, and applicable regulatory standards. It also supports research workflow implementation and management, quality review, and operational support for College of Medicine–Jacksonville research projects. Working collaboratively with investigators, research coordinators, administrators, and institutional stakeholders, the analyst facilitates protocol setup, billing compliance reviews, and research calendar and budget development. The role provides CTMS and institutional-process guidance to study teams, assists with coverage analysis activities, and supports workflow management. It contributes to data integrity, operational efficiency, and regulatory compliance within the Clinical Research Office (CRO) in the Office of Research Affairs, Dean’s Administration, College of Medicine–Jacksonville. This is a time-limited position. A background check and health assessment are required. Applicants must submit a cover letter, resume/CV, and contact information for three references. Work visa sponsorship is not available.
Requirements
- Bachelor’s degree in an appropriate area and one year of relevant experience, or an equivalent combination of education and experience.
- Ability to meet the stated background check and health assessment requirements.
- Eligibility to work in the United States; work visa sponsorship is not available.
Nice To Haves
- One year of experience in clinical research administration and/or financial management in an academic or 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.
- Problem-solving, critical-thinking, and creative skills.
- Strong time-management, organizational, documentation, attention-to-detail, and task-follow-up skills.
- Experience using Microsoft Office applications.
Responsibilities
- Assist with protocol coverage analyses in the CTMS and support the completion and review of Medicare Coverage Analyses (MCAs).
- Review vendor-provided MCAs and assist with validation and completion according to institutional coverage analysis standards; manage coverage analysis requests in a timely and professional manner.
- Complete intake submission assessments for new clinical research studies and assist with research billing compliance reviews, ensuring required documentation is complete and accurate.
- Review study-related documents for adherence to institutional guidelines and regulatory requirements.
- Prepare Financial Language Assessments (FLAs) for informed consent forms when applicable.
- Manage an assigned protocol portfolio in the CTMS and maintain accurate protocol records.
- Build and maintain billing grids and manage Office of Clinical Research workflows in the CTMS.
- Serve as a resource for study teams using the CTMS and assist with troubleshooting and record corrections.
- Monitor workflow timelines and ensure tasks are completed according to established procedures.
- Build sponsor-paid protocol calendars and budgets in the CTMS; coordinate with study teams, fiscal teams, and coverage analysis staff to ensure accuracy and completeness.
- Submit and respond to vendor queries, perform quality assurance reviews of vendor-developed calendars and budgets, and make edits and updates as needed.
- Liaise with investigators, study teams, administrators, and institutional offices.
- Provide technical assistance and guidance to departmental staff and research personnel on sponsor policies and institutional requirements.
- Help identify system issues and communicate defects or workflow concerns to CTMS management or vendor representatives.
- Participate in CTMS testing and validation during system upgrades and implementation of new functionality.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
