The Clinical Research Associate will coordinate, conduct and evaluate research related activity for clinical research projects as assigned. The primary purpose of this position is to oversee the regulatory component of the clinical trials as well as screening, enrollment and retention of student participants, to coordinate study visits, ensure quality of data collected throughout the research study, and implement the procedures and activities of the assigned study protocols, according to all applicable regulations and regulatory compliance, under the direction of the Principal Investigator and the Director of Clinical Research.
The Clinical Research Associate will handle the start-up and maintenance of regulatory process of the clinical trial studies managed by the OCR. The primary purpose of this position is to oversee the regulatory component of the clinical trials activities of the assigned study protocols, according to all applicable regulation and regulatory compliance, under the director of the Principal Investigator and Director of Clinical Research.
- Manage study Master Investigator File in the Florence platform. Fulfill required certification or registration processes when assigned to research projects where study visit activity occurs at Affiliate Institutions.
- Manage new study start-up regulatory documents, including Form FDA 1572-Statement of Investigator, curricula vitae, financial disclosures, etc.
- Prepare, process and submit regulatory documents and applications including consent forms to the Institutional Review Board(s) and other research review boards and committees as applicable and according to regulatory and institutional requirements.
- Communicate with PI and site staff, project sponsors and CROs, and review committees to ensure accuracy of regulatory documents and submissions. Track stud approvals and expirations to ensure uninterrupted project approvals. Maintain regulatory files for assigned protocols. assure all reporting requirements are met per regulator and institutional policies and procedures.
- Assist in the day to day operations of the Clinical Research Center (CRC) including the coordination of clinical research study activities amongst all users of this shared resources. Assist with the development and dissemination of policies, procedures, and site SOPs for the CRC. Ensure quality assurance of research activities conducted in the CRC. Serve as a CRC liaison with investigators, study staff, USF Health Care, and research volunteers as we as research sponsors and Clinical Research Organizations (CROs).
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:
- Human subjects protections training, knowledge of the Code of Federal Regulations, GCP (Global Good Clinical Practice).
FLSB1310 Equivalency:
4 years of directly relevant experience may be substituted for bachelor's degree.
6 years of directly relevant experience may be substituted for master's degree.
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 :
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.
