University of South Florida
Overview
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, research staff, affiliate partners and research volunteers. The strategic services, education and training, and comprehensive review process provide 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. Maintain accurate and up‑to‑date trial information on ClinicalTrials.gov. Monitor compliance with reporting requirements and deadlines.
Scientific and Operational Communication: Present updates on study progress, enrollment and safety 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 administering 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, 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 the 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;
(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.
Minimum qualifications that require a high school diploma are exempt from SB 1310.
About 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.
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.
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 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.
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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. Maintain accurate and up‑to‑date trial information on ClinicalTrials.gov. Monitor compliance with reporting requirements and deadlines.
Scientific and Operational Communication: Present updates on study progress, enrollment and safety 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 administering 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, 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 the 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;
(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.
Minimum qualifications that require a high school diploma are exempt from SB 1310.
About 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.
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.
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 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.
#J-18808-Ljbffr