Clinical Research Coordinator I

University of Central Florida; Orlando (FL); On-site; USD 56,000 - 69,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Flexible Spending

Employee Assistance Program

Paid time off

Retirement savings

Employee discounts

Education assistance

Job summary

The University of Central Florida College of Medicine is seeking an experienced clinical research professional to provide expert support to the Manager-Clinical Trials in business development, start-up, quality assurance, study operations, and study closure for clinical research projects and clinical trials.

Responsibilities include coordinating with sponsors, monitors, auditors, and investigators to ensure activation, regulatory compliance, and efficient study conduct, from feasibility through

Qualifications

• Bachelor's orMaster's degree with 2+ years of relevant experience.
• Experience with regulatory submissions and IRB/FDA applications.
• Experience with clinical trials and data management.
• Ability to work with sponsors, monitors, and auditors.
• U.S. work authorization; visa sponsorship not available.

Responsibilities

• Assist with business development by building rapport with industry sponsors and funders.
• Navigate start-up and close-out processes for clinical research projects and trials; prepare regulatory submissions.
• Assist with clinical research budgets, procurement, and study accounts.
• Coordinate study activities: consent sessions, data collection, scheduling site visits, data entry into EMR/CRFs.
• Ensure compliance with protocols and Good Clinical Practice; prepare for audits and monitor visits.
• Serve as a resource for stakeholders and community regarding clinical research.

Skills

Stakeholder management

Regulatory knowledge

Clinical research

Budgeting

Communication

Data management

Education

Bachelor's or Master's degree

Tools

IRB submission systems

ClinicalTrials.gov

Job description

The Opportunity:

The University of Central Florida College of Medicine is seeking an experienced clinical research professional to provide expert support and assistance to the Manager-Clinical Trials in business development, start-up, quality assurance, study operations, and study closure for clinical research projects and clinical trials.

Responsibilities:

• Assist with business development by building rapport and relationships with industry sponsors, grantors, and funders. Assist with identifying new opportunities. Work with stakeholders to resolve issues and communicate progress. Working with Sponsors, Monitors, and Auditors for site qualification visits, site initiation visits, and monitoring visits. Participate in and support internal and external meetings, site visits, and special events.
• Expertly navigate for the start-up and close-out processes for clinical research projects and clinical trials. Advance studies from initial intake and feasibility through budget, contract, regulatory, ancillary review, and activation, interfacing with other institutional units and partners providing activation support. Independently prepare initial and ongoing UCF IRB, central IRB, FDA applications, and ClinicalTrials.gov applications. Complete other internal regulatory applications, preparing regulatory reports and performing the regulatory reporting requirements of COM clinical research. Interacting with COM faculty and staff regarding regulatory requirements. Prepare studies for privacy officer review.
• Assist with clinical research finance functions- formulating budgets, assessing inventory, requesting procurements, overseeing gift cards, overseeing study accounts. Accepting and returning equipment. Ensuring all equipment needed for clinical trials are present and calibrated. Working with new vendors for set-up, and liaise with vendors for continued services and support.
• Doing study coordination as needed; marketing studies; informed consent sessions; study data collection; communicating with study participants; scheduling study visits; data entry into the electronic medical records. Maintain up-to-date and correct information in the electronic regulatory system. Data entry of de-identified information into electronic case report forms. Follow state and federal regulations, specific protocol requirements, and Good Clinical Practice Guidelines.
• Work collaboratively with investigators, sub-investigators, referring physicians, patients and their families, and other research staff. Serve as a resource for both internal and external stakeholders and members of the community in regard to clinical research.
• Constantly review studies for quality. Ensure compliance with research protocols, review case report forms and audits for accuracy with source documents. Prepare for internal and external monitor or audit visits, including FDA audits. Attends site monitoring meetings with sponsors. Provide training and guidance for quality for other research staff. Complete adverse event and protocol deviation reporting.
• Serve as delegate in the absence of the manager for all business processes and approval of time sheets. Serve as a project manager for short-term, business-related projects.
• Other activities as assigned by the Clinical Research Manager or the study principal investigator including maintenance of training and required certifications; attend meetings as assigned; and other assigned administrative duties. timely completion of required university and college trainings and updates.

Minimum Qualifications:

Bachelor's or Master's degree and 2+ years of relevant experience, or an equivalent combination of education and experience pursuant to Fla. Stat. 112.219(6).

Preferred Qualifications:

• Certification with CCRP - Certified Clinical Research Professional (SOCRA), CCRC.
• Certified Clinical Research Coordinator (ACRP), and/or CTBS- Certified Tissue Bank Specialist (AATB).
• At least 2 years’ experience with clinical trials.
• Experience with data management.
• Experience with patient care.

Additional Application Materials Required:

In addition to your application, please submit a resume.

Special Instructions to the Applicants:

• The anticipated salary range for this position is $56,030.00 - $68,637.00. The final salary will be determined based on the candidate's qualifications, experience, and internal equity considerations.
• All applicants must be authorized to work for any U.S. employer. Visa sponsorship is not available for this position, and the university cannot accommodate H-1B transfers or employment-based visa processing for individuals currently sponsored by another employer.
• This position requires a valid Class E driver's license. This position may involve driving to various locations on and off campus to conduct University business.

Are you ready to unleash YOUR potential?

As a next-generation public research university and Forbes-ranked top employer in Florida, we are a community of thinkers, doers, creators, innovators, healers, and leaders striving to create broader prosperity and help shape a better future. No matter what your role is, when you join Knight Nation, you'll play an integral role at one of the most impactful universities in the country. You'll be met with opportunities to connect and collaborate with talented faculty, staff, and students across 12 colleges and multiple campuses, engaging in impactful work that makes a positive difference. Your time at UCF will provide you with many meaningful opportunities to grow, you'll work alongside talented colleagues on complex projects that will challenge you and help you gain new skills, and you'll have countless rewarding experiences that go well beyond a paycheck.

Working at UCF has its perks!UCF offers:

• Benefit packages, including Medical, Dental, Vision, Life Insurance, Flexible Spending, and Employee Assistance Program
• Paid time off, including annual and sick time off and paid holidays
• Retirement savings options
• Employee discounts, including tickets to many Orlando attractions
• Education assistance
• And more…For more benefits information, view UCF Employee Benefits Guide.

Dive into our Total Rewards Calculator to discover the diverse selection available to you, giving you a glimpse into the benefits that together shape your comprehensive rewards package at UCF.

Additional Requirements related to Research Positions:

Pursuant to Florida State Statute 1010.35, prior to offering employment to certain individuals in research-related positions, UCF is required to conduct additional screening. Applicants subject to additional screening include any citizen of a foreign country who is not a permanent resident of the U.S., or who is a citizen or permanent resident but is affiliated with or has had at least 1 year of education, employment, or training in China, Cuba, Iran, Russia, North Korea, Syria, or Venezuela.

The additional screening requirements only apply to research-related positions, including, but not limited to faculty, graduate positions, individuals compensated by research grants or contract funds, postdoctoral positions, undergraduate positions, visiting assistant professors, and visiting research associates.

Department

College of Medicine (COM) - Dean's Office

Work Schedule

Monday - Friday; 8:00 AM- 5:00 PM; May need to work evenings or weekends as needed and travel occasionally.

Type of Appointment

Regular

Expected Salary

$56,030.00 to Negotiable

Job Posting End Date

11-10-2026-12-00-AM

The University of Central Florida is an equal opportunity employer that does not discriminate against any employee or applicant for employment based on any characteristic protected by law. The University maintains programs for protected veterans and individuals with disabilities in accordance with all applicable federal and state laws.

As a Florida public university, the University of Central Florida makes all application materials and selection procedures available to the public upon request.

UCF is proud to be a smoke-free campus and an E-Verify employer.