Clinical Research Coord II

University of Florida • Gainesville, FL

19h • Onsite

About The Position

The Department of Ophthalmology is seeking a Clinical Research Coordinator II (CRC) to fill a pivotal role in essential administrative coordination and management of clinical trials. Under the general direction of the Department Chair, department administration, and the designated Principal Investigator (PI) for each project or trial, the CRC will be involved in initial preparation of proposal including contract negotiations and budget preparation; design and conduct research activities; and ensure proper closure of trials. The CRC will set-up and monitor studies, complete accurate study status reports, and maintain study documentation. This incumbent will assist with regulatory documents and related start up activities including submission to IRB and preparing regulatory submissions. Must be familiar with the various research-related compliance aspects and the policies that govern clinical trial administration required by the University of Florida and Institutional Review Boards. Candidates should possess the ability to independently prioritize, plan, and organize work activities as well as establish and maintain effective working relationships with others. As a key member of our team, you will empower investigators and clinicians to focus on science by expertly managing the administrative complexities of clinical studies for the Department of Ophthalmology. This position offers an excellent opportunity to support impactful research within a collaborative, mission-driven department.

Requirements

• Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
• Familiarity with the various research-related compliance aspects and the policies that govern clinical trial administration required by the University of Florida and Institutional Review Boards.
• Ability to independently prioritize, plan, and organize work activities.
• Ability to establish and maintain effective working relationships with others.

Nice To Haves

• Strong organizational and multitasking abilities.
• Skilled in problem-solving and decision-making.
• Excellent interpersonal skills to engage investigators, sponsors, and study participants and the ability to effectively communicate in verbal and written formats.
• Adept at troubleshooting and maintaining research-related technology and software tools.
• Ability to draft clear documentation, training guides, and standard operating procedures to support study compliance and operational continuity.
• Experience working with IRB protocols and regulatory compliance.
• Familiarity with EPIC, UFIRST, OnCore, REDCap or other research data platforms.

Responsibilities

• Plan and execute day-to-day operations of the Clinical Trials Program to facilitate the preparation, execution, and closure of clinical research studies.
• Assist in study closure activities, including file review, final site visits, and preparation of closeout reports for IRB approval.
• Provide support to investigators in compiling and evaluating data for publication.
• Coordinate the collection, analyses, compilation, and submission of information and data as needed.
• Utilize management systems such as UFIRST, OnCore, and REDCap to execute research protocols, track study progress and milestones, and oversee site communication and collaboration.
• Obtain and negotiate ophthalmic clinical research contracts with industry sponsors and oversee the operations of the Clinical Trials Program to comply with these contracts and ophthalmic clinical research grants from the National Eye Institute.
• Identify key study personnel, ensure their certification and training meet sponsor requirements, and coordinate clinical services, including patient care appointment and staff scheduling.
• Comply with Institutional Review Board (IRB) regulations, assist with IRB/Sponsor correspondence, and prepare necessary protocols and informed consent documents.
• Coordinate patient recruitment, data collection, and clinical services in line with study protocols.
• Meet with study sponsors for initiation visits, recruitment strategies, and investigator obligations, ensuring compliance with FDA and IRB regulations.
• Arrange visits in coordination with ophthalmology clinic staff, collect and report data to sponsors, and collaborate with certified ophthalmic technicians (COTs) to prepare for investigator study visits.
• Utilize UF Health EMR to obtain study specific medical record documentation and conduct billing reviews.
• Monitor operating budgets of clinical research studies to ensure that sponsor invoicing, human subject payments, clinical service fees, and study expenditures are in accordance with contract terms.
• Perform a variety of accounting functions, which include preparing, reviewing, and approving documents; reconciling P-Card transactions; monitoring fund balances; preparing status reports; and performing other related activities.

Benefits

• Health, Dental & Vision Insurance
• Staff Retirement Plans
• Paid Time Off (approximately 22 days of vacation leave, 13 days of sick leave and 11 paid holidays annually)
• Tuition Assistance (UF Employee Education Program)
• Public Service Loan Forgiveness (PSLF) Eligible Employer

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees