Clinical Research Analyst I

University of Florida•Jacksonville, FL

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), in the Clinical Research Office, Office of Research Affairs, Dean’s Administration, College of Medicine–Jacksonville. The role 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 CTMS research workflows and provides quality review and operational support for research projects across the College of Medicine–Jacksonville. The analyst collaborates with investigators, research coordinators, administrators, fiscal teams, coverage analysis staff, and institutional stakeholders. The role supports protocol setup, billing compliance reviews, research calendar and budget development, coverage analyses, and workflow management. It also provides technical assistance and guidance to study teams using the CTMS and institutional processes, helps maintain data integrity and operational efficiency, and supports regulatory compliance across the clinical research portfolio.

Requirements

Bachelor's degree in an appropriate area and one year of relevant experience, or an equivalent combination of education and experience.
Upload a cover letter, resume/CV, and contact information for three references.
Must be eligible to work in the United States; work visa sponsorship is not available.
Degrees earned outside the United States must be evaluated by a professional credentialing service provider approved by the National Association of Credential Evaluation Services (NACES).
A background check is required.
A health assessment is required.

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, remain flexible, and stay on task in a high-paced, high-volume professional environment.
Problem-solving, critical-thinking, and creativity 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 Clinical Trials Management System (CTMS).
Support the completion and review of Medicare Coverage Analyses (MCAs) with team members.
Review vendor-provided MCAs and assist with validation and completion in alignment with institutional coverage analysis standards.
Manage coverage analysis requests in a timely and professional manner.
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 for adherence to institutional guidelines and regulatory requirements.
Prepare Financial Language Assessments (FLAs) for informed consent forms when applicable.
Manage an 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 using the CTMS and assist with troubleshooting or record corrections.
Monitor workflow timelines and ensure tasks are completed according to established procedures.
Build 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 reviews of calendars and budgets developed through the vendor system.
Make edits and updates during the calendar and budget development process.
Serve as a liaison among 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 testing and validation of the CTMS during system upgrades and implementation of new functionality.