Job Description
This position plans, organizes, and manages the resources necessary to achieve clinical research project goals and objectives. The position assembles, trains and manages the team assigned to the project. The position documents procedures for the research project and manages reporting and compliance activities, serving as the overall head of project operations.
Nature of Work: This position typically reports to the principal investigator of a clinical research study or to an administrator, such as an Assistant Director who oversees many projects. The position may develop protocols and prepare operations manuals at the initiation of a research study. The position then performs project activities such training and indirectly (or directly) supervising project staff, developing materials to communicate the project to potential clients and their families, making site visits to audit activities, ensuring quality control in the data through resolution of inconsistencies, and compiling regulatory reports. The position acts as the primary resource for explaining the project all parties involved. 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. Sr. Clinical Research Associates typically oversee staff who are assigned to the project but may not directly supervise. Sr. Clinical Research Associates 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, but the primary purpose is to oversee and conduct the principal project activities.
Responsibilities Oversees and designs protocols and electronic case report forms. Develops manual of operations. Reviews medical protocol and prepares draft of document. Coordinates with protocol project manager and study chair preparation of final document for research staff training. Updates the protocols as needed and maintain document version control. Throughout the tenure of the medical protocol, update as needed with Study Chair as appropriate. Trains indirect and/or direct reports on policies and procedures, operations, adverse event resolution, protocol creation and review, case report form creation and review, and site data adherence and compliance. 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. Manages addition of new sites to the network and develops and maintain policies, templates, and related documents for new site additions. Develops and interprets policy governing data systems, data collection procedures and database validation studies to be in compliance with federal guidelines (Good Clinical Practice, GCP). Collects and analyzes data from clinical trials or other medical screening. Creates data bases based client information or medical records, and analyzes data. Coordinates conference calls and meetings and prepare necessary meeting documents (agendas, minutes, handouts, reports, etc.), develops related standards, templates and processes. Acts as point of contact and support for consortia research staff.
Qualifications This position requires a Bachelor's degree in a field directly related to the program responsibilities and three years of professional experience; or Master's degree in an area of specialization appropriate for the program and one year of professional experience.
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.
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 .
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 does not constitute an employment contract.
Job Tags
Full time, Contract work, Work experience placement,