University of South Florida
Job Description
The mission of the Office of Clinical Research (OCR) is to provide faculty with resources, information and expertise in clinical research to advance knowledge related to human disease and healthcare. The OCR facilitates the process of conducting clinical research, from inception through completion, with the goal of scientific discovery to facilitate prevention, diagnosis, and treatment of disease and to improve healthcare. We are committed to streamlining procedures and enhancing services for clinical investigators and research staff, affiliate partners, extramural sponsors and research volunteers. The strategic services, education and training, and comprehensive review process provided by the OCR are designed to foster research teams throughout the USF community. OCR is managed within the Office of Research for the Morsani College of Medicine.
The Clinical Research Manager for the Hyperbaric Oxygen Therapy (HBOT) program at the University of South Florida (USF) Health will oversee and coordinate all operational and regulatory aspects of a groundbreaking clinical trial investigating the efficacy of HBOT in alleviating symptoms of traumatic brain injury (TBI) among Florida's veteran, active duty, and reserve service members. Supported by a grant from the Florida Legislature, this fast-paced, high-impact study includes an aggressive timeline, an intense study visit schedule, and may require extended office hours, including nights and occasional weekends.
Responsibilities
Team Management and Oversight: Supervise and mentor direct reports, including clinical research coordinators and associates. Provide ongoing training and development opportunities to ensure team competence in protocol procedures, regulatory compliance, and operational tasks. Conduct performance evaluations, set goals, and support career growth of team members.
Study Operations: Oversee day-to-day clinical trial operations, including participant recruitment, scheduling, study visits, data collection, and specimen management. Review and approve protocol amendments, supporting documents, and study materials. Ensure all study activities are conducted according to protocol, SOPs, and GCP guidelines
ClinicalTrials.gov and FDA Submissions: Prepare, review, and submit all required FDA documentation, including annual reports, protocol amendments, safety reports, and other regulatory filings. Ensure timely and accurate responses to FDA inquiries or requests. Maintain compliance with federal, state, and institutional regulatory requirements throughout the study. Ensure all clinical trial information is accurately entered, updated, and maintained on ClinicalTrials.gov. Monitor compliance with reporting requirements and deadlines.
Scientific and Operational Communication: Present updates on study progress, enrollment, safety, and operational metrics at scientific and operational committee meetings. Act as a liaison between investigators, study staff, institutional leadership, and external collaborators. Prepare reports, summaries, and presentations to communicate trial progress and outcomes.
Research Day and other duties as directed.
Qualifications
Minimum Qualifications:
• Bachelor's degree in a related field. • 5+ years of experience in a related field.
Preferred Qualifications: Veteran status strongly preferred, or experience working with veteran populations. Direct clinical research experience, including patient interaction in a clinical or research setting. Previous experience as a psychometrist, with demonstrated proficiency in administrating and scoring neuropsychological assessments. Strong background, education, or special interest in neuropsychology, cognitive neuroscience, or related fields. Experience working with populations requiring neuropsychological assessments, such as individuals with traumatic brain injury (TBI), neurodegenerative disorders, or cognitive impairment. Knowledge of regulatory requirements, clinical trial protocols, and research compliance in a healthcare or academic setting. Excellent organizational and communication skills, with he ability to engage with multidisciplinary teams, research participants, and study sponsors.
Degree Equivalency Clause: Four years of direct experience for a bachelor's degree. • 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.
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 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.
The mission of the Office of Clinical Research (OCR) is to provide faculty with resources, information and expertise in clinical research to advance knowledge related to human disease and healthcare. The OCR facilitates the process of conducting clinical research, from inception through completion, with the goal of scientific discovery to facilitate prevention, diagnosis, and treatment of disease and to improve healthcare. We are committed to streamlining procedures and enhancing services for clinical investigators and research staff, affiliate partners, extramural sponsors and research volunteers. The strategic services, education and training, and comprehensive review process provided by the OCR are designed to foster research teams throughout the USF community. OCR is managed within the Office of Research for the Morsani College of Medicine.
The Clinical Research Manager for the Hyperbaric Oxygen Therapy (HBOT) program at the University of South Florida (USF) Health will oversee and coordinate all operational and regulatory aspects of a groundbreaking clinical trial investigating the efficacy of HBOT in alleviating symptoms of traumatic brain injury (TBI) among Florida's veteran, active duty, and reserve service members. Supported by a grant from the Florida Legislature, this fast-paced, high-impact study includes an aggressive timeline, an intense study visit schedule, and may require extended office hours, including nights and occasional weekends.
Responsibilities
Team Management and Oversight: Supervise and mentor direct reports, including clinical research coordinators and associates. Provide ongoing training and development opportunities to ensure team competence in protocol procedures, regulatory compliance, and operational tasks. Conduct performance evaluations, set goals, and support career growth of team members.
Study Operations: Oversee day-to-day clinical trial operations, including participant recruitment, scheduling, study visits, data collection, and specimen management. Review and approve protocol amendments, supporting documents, and study materials. Ensure all study activities are conducted according to protocol, SOPs, and GCP guidelines
ClinicalTrials.gov and FDA Submissions: Prepare, review, and submit all required FDA documentation, including annual reports, protocol amendments, safety reports, and other regulatory filings. Ensure timely and accurate responses to FDA inquiries or requests. Maintain compliance with federal, state, and institutional regulatory requirements throughout the study. Ensure all clinical trial information is accurately entered, updated, and maintained on ClinicalTrials.gov. Monitor compliance with reporting requirements and deadlines.
Scientific and Operational Communication: Present updates on study progress, enrollment, safety, and operational metrics at scientific and operational committee meetings. Act as a liaison between investigators, study staff, institutional leadership, and external collaborators. Prepare reports, summaries, and presentations to communicate trial progress and outcomes.
Research Day and other duties as directed.
Qualifications
Minimum Qualifications:
• Bachelor's degree in a related field. • 5+ years of experience in a related field.
Preferred Qualifications: Veteran status strongly preferred, or experience working with veteran populations. Direct clinical research experience, including patient interaction in a clinical or research setting. Previous experience as a psychometrist, with demonstrated proficiency in administrating and scoring neuropsychological assessments. Strong background, education, or special interest in neuropsychology, cognitive neuroscience, or related fields. Experience working with populations requiring neuropsychological assessments, such as individuals with traumatic brain injury (TBI), neurodegenerative disorders, or cognitive impairment. Knowledge of regulatory requirements, clinical trial protocols, and research compliance in a healthcare or academic setting. Excellent organizational and communication skills, with he ability to engage with multidisciplinary teams, research participants, and study sponsors.
Degree Equivalency Clause: Four years of direct experience for a bachelor's degree. • 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.
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 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.