Clinical Research Associate

The Clinical Research Associate 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 requires an on-site presence and regular travel to locations within the health system.
This position is grant funded.
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 and USF Health. In 2025, U.S. News & World Report recognized USF with its highest overall ranking in university history, as a top 50 public university for the seventh consecutive year and as one of the top 15 best values among all public universities in the nation. U.S. News also ranks the USF Health Morsani College of Medicine in the highest tier, placing it as one of the top 16 medical schools in the nation and inside the top 10 among public universities. 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 $750 million in research funding in 2025 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 nearly $10 billion for the state of Florida. USF’s Division I athletics teams compete in the American Conference. Learn more at www.usf.edu.

• Responsibilities include coordinating protocol implementation, collaborating with hospital departments (IT, pharmacy, nursing, physician groups, and administration), facilitating clinical workflows and electronic health record order sets, developing and delivering training for clinical staff, supervising research personnel, managing study documents and budgets, and ensuring project milestones are met..
• 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.

Minimum 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.

Preferred Qualifications:

Preference will be given to candidates with experience in substance use disorder research, behavioral health, emergency medicine, clinical research, or healthcare operations.
Senate Bill 1310- The Florida Senate (https://www.flsenate.gov/Session/Bill/2023/1310) is conditional upon meeting all employment eligibility requirements in the U.S.
SB 1310: Substitution of Work Experience for Postsecondary Education Requirements

• A public employer may include a postsecondary degree as a baseline requirement only as an alternative to the number of years of direct experience required, not to exceed:
• (a) Two years of direct experience for an associate degree;
• (b) Four years of direct experience for a bachelor's degree;
• (c) Six years of direct experience for a master's degree;
• (d) Seven years of direct experience for a professional degree; or
• (e) Nine years of direct experience for a doctoral degree
• Related work experience may not substitute for any required licensure, certification, or registration required for the position of employment as established by the public employer and indicated in the advertised description of the position of employment.
• Minimum Qualifications that require a high school diploma are exempt from SB 1310.