Clinical Research Associate Jobs in Spring Hill, FL

Nature of Work: This work involves many aspects of a traditional clinical research coordinator-arranging and facilitating timely study visits, ensuring quality of data collected throughout the research study, and implementing procedures and activities of the assigned study protocols, according to all applicable regulations and regulatory compliance, under the direction of the Director of Clinical Research & Principal Investigator.

This position is time limited.

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.  

 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.
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.

• Recruit, screen, and provide research-related services, interventions, and evaluations per protocol for participants enrolled in OB/GYN clinical research studies under the direction of the Principal Investigator (PI). Provide initial and ongoing informed consent with participants and families. Schedule study visits and procedures and follow-up study visits per protocol visit windows. Administer investigational product per protocol. Perform study-related procedures such as collection of vital signs, phlebotomy, and other procedures per protocol as delegated by the PI and in accordance with training and experience. Communicate participant status to Investigator and research team as well as other entities as required. Strive to enhance subject retention in assigned protocols. Assure all reporting requirements are met per regulatory and institutional policies.
• Compile and maintain research progress notes and source documents and record data for each study participant in accordance with the research protocol. Monitor participants' unexpected and adverse events, laboratory, radiology, and other procedure test results, and report to Investigator, sponsor, and IRB (Institutional Review Board) as appropriate. Collect and report study data on paper Case Report Forms or in electronic data capture systems per protocol, including query resolution. Develop source document templates as needed per protocol. Monitor clinical study activity to ensure compliance with the protocol, site SOPs (Standard Operating Procedures), and all applicable regulations, including HIPAA (Health Insurance Portability and Accountability Act) regulations.
• Prepare and submit documents to the Institutional Review Board(s) and other research review boards and committees as applicable and according to regulatory and institutional requirements. Compile and maintain regulatory files for assigned protocols. Coordinate, prepare for, and participate in monitoring visits, audits, and inspections.
• Collect, process, and ship research specimens. Achieve and maintain certification in bio-hazardous materials shipping. Ensure that infection control and safety procedures are implemented and maintained. Maintain investigational article accountability records and manage clinical supplies as required for assigned protocols. Interface with Investigational Pharmacy and Affiliate Institutions for assigned studies as applicable. Fulfill required certification or registration processes when assigned to research projects where study visit activity occurs at Affiliate Institutions.
• Educate patients, families, and staff in regard to clinical research activity. Complete and maintain necessary training to stay abreast of current regulatory guidelines. Participate in the planning and execution of education and training activities, specific to assigned studies and to general clinical research educational activities. Serve as a resource for both internal and external customers and members of the community in regard to clinical research processes, developments, and trends in the field, as well as referrals to specific OB/GYN clinical research studies as applicable.
• Performs other duties as assigned.