Clinical Research Analyst I

University of Florida•Jacksonville, FL

5d•$53,000 - $60,000

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) for the Clinical Research Office in the Office of Research Affairs, Dean’s Administration, College of Medicine–Jacksonville. The position assists with developing, reviewing, and maintaining clinical research protocols and related documentation to ensure compliance with institutional policies, sponsor requirements, and applicable regulatory standards. It supports implementation and management of research workflows in the CTMS and provides quality review and operational support for research projects across the College of Medicine–Jacksonville. The analyst collaborates with investigators, research coordinators, administrators, and institutional stakeholders to facilitate accurate protocol setup, billing compliance reviews, and research calendar and budget development. The role provides technical support and guidance to study teams on CTMS use and institutional processes, assists with coverage analysis activities, and supports workflow management to ensure assigned tasks are completed accurately and on time. It contributes to data integrity, operational efficiency, and regulatory compliance for the CRO’s 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.
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 creative skills.
Strong time management, organizational, documentation, attention-to-detail, and task follow-up skills.
Experience using Microsoft Office applications.

Nice To Haves

One year of experience in clinical research administration and/or financial management in an academic or medical setting.
Familiarity with OnCore CTMS by Advarra or similar clinical trial management software.

Responsibilities

Assist with protocol coverage analyses in the CTMS and support completion and review of Medicare Coverage Analyses (MCAs).
Review vendor-provided MCAs and assist with validating and completing them to meet 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 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 or 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 calendars and budgets developed through the vendor system, and make 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.