Clinical Research Analyst I

Classification Title:

Clinical Research Analyst I

Classification Minimum Requirements:

Bachelors 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) Deans Administration College of MedicineJacksonville is seeking a Clinical Research Analyst I to support clinical trial operations and protocol management within the University of Floridas 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 MedicineJacksonville.
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 AssessmentsComplete 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.

Expected Salary:

$53000-$60000

Required Qualifications Bachelors degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.

Preferred:

The ideal candidate will possess:

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.

Special Instructions to Applicants:

This is a time-limited position. Time limited positions are based on circumstances such as funding sources which control the length of time for which the position is available.

Background Check is Required.

To be considered you must upload your Cover Letter Resume/CV and contact information for 3 References.

University of Florida College of Medicine Jacksonville: Visit this link to watch the video.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

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 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 Floridas Sunshine Law

Health Assessment Required: Yes

Required Experience:

IC