Clinical Research Analyst I

University of Florida; Jacksonville (FL); On-site; USD 53,000 - 60,000; Full time

Job summary

University of Florida seeks a Clinical Research Analyst I to support protocol development, CTMS workflow management, and regulatory compliance across the College of Medicine-Jacksonville. The role collaborates with investigators, study teams, and administrative offices to ensure accurate budgeting, billing and timely task completion.

The analyst will assist with Medicare coverage analyses, data integrity within CTMS, and quality reviews of research documentation, with emphasis on compliance and

Qualifications

• Bachelor's degree in an appropriate area and one year of relevant experience or equivalent.
• Background Check is required.
• Health Assessment required: Yes.
• No visa sponsorship available for this position.
• Degrees earned outside the US must be evaluated by a NACES-approved credential service.

Responsibilities

• Support clinical trial operations and protocol management within the CTMS.
• Assist with protocol development, review, and maintenance to ensure regulatory compliance.
• Provide guidance on CTMS use and workflow management for study teams.
• Perform coverage analyses and support MCA reviews in collaboration with team members.
• Build and maintain billing grids and support sponsor calendars and budgets in CTMS.

Skills

Clinical research

Budget management

Regulatory compliance

CTMS experience

Education

Bachelor's degree

Tools

CTMS (OnCore)

Microsoft Office

Job description

Classification

Title: Clinical Research Analyst I

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

Job Description

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.

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. 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.

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 review of calendars and budgets developed through the vendor system.

Make edits and updates as necessary throughout the calendar and budget development process.

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.

Salary

$53,000-$60,000

Required Qualifications

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

Background Check is Required.

Health Assessment Required: Yes

Work Visa sponsorship is not available for this position.

Degrees earned from an education institution outside of the United States are required to be evaluated by a professional credentialing service provider approved by the National Association of Credential Evaluation Services (NACES), which can be found at http://www.naces.org/ .

The University of Florida is a public institution and subject to all requirements under the Florida Sunshine and Public Records laws. Hiring is contingent upon eligibility to work in the US. Searches are conducted in accordance with Florida's Sunshine Law

Preferred

• 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.