Clinical Research Associate

Job Description

This position collects and manages patient and / or laboratory data for a clinical research project. The position oversees the screening and enrollment of clients, gathers and analyzes data on health care programs, develops databases , analyzes data, ensures quality control, and compiles reports for regulatory compliance.

Nature of Work : This position typically reports to the principal investigator of a clinical research study. The position may perform evaluation duties in preparation for the project. The position then performs project activities such as overseeing the screening and enrollment of potential clients for a health services protocol, developing materials to communicate the project to potential clients and their families, coordinating site visits and appropriate collection of data, ensuring quality control in the data, and compiling regulatory reports. This position may require specific computer expertise and may require maintaining information on a web site. Work at this level meets the FLSA criteria for a professional exemption since the primary duties are work that requires advanced knowledge, which is predominantly intellectual in character and requires the consistent exercise of discretion and judgment. Clinical Research Administrators typically oversee temporary staff or Research Support Specialists. They differ from the non-exempt staff by developing techniques and overseeing clinical data gathering, establishing quality control standards, composing educational materials, and acting as liaison with regulatory agencies. Clinical Research Administrators are not overall project directors. They do not set overall project direction nor do they have responsibility for final interpretation of project results. This position may perform some general administrative duties such as monitoring budgets, and drafting administrative forms and reports. Work is distinguished from an Administrative and Business Analyst through its primary emphasis on overseeing client recruiting and testing, and analyzing clinical data rather than general administrative work.

This Position is Grant-Funded.

Responsibilities

• Oversees medical or health recruiting and screening protocols, collecting data for research studies. May oversee remote screening locations. Monitors laboratory tests and referrals.
• Recruits and trains assistants who gather data.
• Monitors compliance of study procedures with Federal, state and university regulations. Ensures that documents such as eligibility forms and informed consent are appropriately gathered and maintained, HIPAA regulations are followed, and that infection control, and safety procedures are implemented.
• Prepares and maintains regulatory and compliance documents such as IRB applications. Interprets rules and regulations pertaining clinical research to ensure compliance in research projects.
• Recommends changes in procedures in order to locate, accept, and track clients.
• Collects and analyzes data from clinical trials or other medical screening. Creates databases for client information or medical records, and analyzes data.
• Collaborates with social workers and professional agencies to provide services related to health conditions.
• Composes and disseminates information on studies to clients and the general public.
• Acts as performance consultant to subcontractors or health departments to produce model quality programs
• Drafts program reports for publication and / or public dissemination.
• Provides education to clients and clients' families regarding clinical protocols.
• Performs other duties as assigned.

Qualifications

This position requires a Bachelor's degree in a field directly related to the program responsibilities and one year of professional experience; or Master's degree in an area of specialization appropriate for the program.

About Us

Working at USF

With approximately 16,000 employees, the University of South Florida is one of the largest employers in the Tampa Bay area. We are dedicated to cultivating a talented, engaged and driven workforce that strives to be bold. Employees excel in USF's rich academic environment, which fosters their development and advancement. In 2025, Forbes recognized USF as one of Florida's best large employers, ranked No. 1 among the state's 12 public universities. Our first-class benefits package includes medical, dental and life insurance plans, retirement plan options, employee and dependent tuition programs, generous leave, and hundreds of employee perks and discounts.

About USF

The University of South Florida is a top-ranked research university serving approximately 50,000 students from across the globe at campuses in Tampa, St. Petersburg, Sarasota-Manatee and USF Health. USF is recognized by U.S. News & World Report as a top 50 public university and the best value in Florida. U.S. News also ranks the USF Health Morsani College of Medicine as the No. 1 medical school in Florida and in the highest tier nationwide. USF is a member of the Association of American Universities (AAU), a group that includes only the top 3% of universities in the U.S. With an all-time high of $738 million in research funding in 2024 and as a top 20 public university for producing U.S. patents, USF uses innovation to transform lives and shape a better future. The university generates an annual economic impact of more than $6 billion. USF's Division I athletics teams compete in the American Athletic Conference. Learn more at www.usf.edu.

Compliance and Federal Notices

This position may be subject to a Level 1 or Level 2 criminal background check.

Applicants have rights under Federal Employment Laws :

The University of South 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.

Family and Medical Leave Act (FMLA)

Applicants for USF employment are entitled to request reasonable accommodation(s) in the application process. A request is to be made at least five (5) working days prior to the time the accommodation(s) is needed. Visit the Central Human Resources ADA Accommodations webpage for more information on requesting an accommodation during the application / interview process.

Equal Employment Opportunity

The University of South 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 affirmative action programs for protected veterans and individuals with disabilities in accordance with all applicable federal and state laws. This job description does not constitute an employment contract.