Clinical Trials Unit

Clinical Trials Unit

Our Clinical Trials Unit (CTU) provides a full range of clinical trial support services to internally funded and collaborative initiatives. It is comprised of mission-driven research professionals, to include: 

  • Director of Clinical Operations
  • Senior Clinical Trials Specialist
  • Senior Regulatory Affairs Specialist
  • Senior Clinical Research Associate
  • Clinical Research Associate
  • Project Study Coordinators

The CTU team members offer unique expertise and extensive experience in the following areas:

  • United States Food and Drug Administration (FDA) Regulatory Affairs
  • Department of Defense and Federal Regulations
  • Cooperative Research and Development Agreements (CRADAs)
  • Multi-site Regulatory Strategy and Regulatory Submissions
  • ClinicalTrials.gov 
  • Clinical Trial Risk-based Monitoring
  • Clinical research within U.S. military populations

Overview of CTU Services

The CTU can assist investigators and study teams with all aspects of their clinical trials. This team collaborates closely with our Clinical Core Facilities and Translational Research Division. Check out our Clinical Trials page for an overview of the CTU's clinical research pipeline.

CTU services include:

  • Project Management
  • Clinical Trial Design/Development
  • Trial Coordination
  • Trial Feasibility Assessment
  • Site Identification and Qualification; Site Management 
  • Trial start-up and close-out activities
  • Regulatory Affairs and Operations
  • Quality Management 
  • Safety Management 
  • Clinical Trial Subject Matter Expertise
  • Clinical Trial Monitoring

Contact Us

Interested in using our CTU to support your clinical trial? Inquiries should be made to cnrm-ctu@usuhs.edu. Regulatory inquiries should be made to cnrm-reg@usuhs.edu.