Clinical Research Analyst II

University of Florida•Jacksonville, FL

11h•Onsite

About The Position

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 II 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 II 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.

Requirements

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

Nice To Haves

Two to three years of experience in clinical research administration and/or financial management in an academic/medical setting.
Experience building clinical trial calendars and budgets in the OnCore CTMS by Advarra or similar clinical trial management software.
Demonstrated ability to independently manage multiple clinical research projects while balancing customer service and research compliance.
Ability to organize and prioritize work effectively in a high-paced, high-volume professional environment.
Strong problem-solving skills with the ability to troubleshoot system and workflow issues.
Excellent time management, organizational, documentation, attention to detail, and task follow-up skills.
Experience in training or supporting end users on research systems or processes.
Proficiency using Microsoft Office applications, particularly Excel.

Responsibilities

Independently build AHC and ONC clinical trial calendars and budgets within the OnCore Clinical Trials Management System (CTMS) in accordance with institutional guidelines and procedures.
Develop and maintain calendars and budgets for new studies, amendments, and updates.
Ensure accurate designation of sponsor-paid versus standard-of-care activities.
Coordinate with study teams to obtain required information for calendar and budget development.
Manage vendor-built calendars and budgets by performing quality checks and validating accuracy.
Implement institutional standard operating procedures (SOPs) during review and approval processes.
Identify and communicate budget-related discrepancies to study teams for review and resolution.
Monitor workflow timelines and ensure timely completion of assigned tasks.
Conduct end-user training for study staff on calendar, budget, and subject management within OnCore CTMS.
Provide guidance to investigators and research teams on institutional processes and system use.
Develop training materials and assist with onboarding of new users.
Serve as an advanced resource for complex questions related to CTMS workflows.
Troubleshoot calendar, budget, and subject management issues within the OnCore CTMS.
Assist with testing system enhancements, upgrades, and new functionality.
Document issues and coordinate with CTMS support teams and vendors to resolve defects.
Validate system changes to ensure proper operation.
Work with support staff to test and validate calendar workflows within Epic.
Collaborate with research, fiscal, and compliance teams to ensure workflow alignment.
Participate in process improvement initiatives to enhance operational efficiency.
Provide recommendations for workflow enhancements and system optimization.