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.

• 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.

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.
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.

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 ae exempt from SB 1310.

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 .

• 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