Clinical Trials Management: Academic Information

The graduate certificate in Clinical Trials Management consists of five required courses delivered in eight-week sessions. In each course, you’ll develop a well-rounded understanding of how clinical trials are designed, conducted, and managed, from study startup and regulatory requirements to data management and trial oversight. 

The graduate-level coursework emphasizes practical application, giving you the opportunity to build skills you can use immediately in professional settings. At the completion of this program, students will be able to:

• Translate scientific hypotheses into operational realities by critically analyzing and contributing to clinical trial protocols, investigator brochures, and case report forms.
• Manage the end-to-end life cycle of a clinical trial, from site selection and participant recruitment through final closeout procedures.
• Oversee clinical data management systems to ensure data integrity, security, and traceability from source document to final study report.
• Lead multidisciplinary trial teams, fostering seamless communication between principal investigators, sponsors, clinical research coordinators, and trial monitors.
• Use project management frameworks to balance trial timelines, resource allocation, and vendor relationships, including coordination with Clinical Research Organizations.
• Apply ethical principles of responsible research conduct and Good Clinical Practice standards to mitigate risk and ensure compliance in research settings.

As you move through this clinical practice training program at your own pace, you’ll gain experience working with the tools, processes, and standards that support clinical trials across health systems, research organizations, and pharmaceutical environments. 

The certificate is built to be flexible, so you can easily balance your work and life with your studies. While it is recommended to begin with the introductory course, you can complete courses in a sequence that works for you.

Learn more about the curriculum and required courses

HMGT 700 Introduction to Clinical Trials and Good Clinical Practice

HMGT 701 Clinical Trial Design and Protocols

HMGT 702 Clinical Trial Operations and Management

HMGT 703 Regulatory Affairs and Compliance in Clinical Research

HMGT 704 Clinical Data Management and Quality Assurance

The certificate curriculum is aligned with the Harmonized Core Competency Framework developed by the Joint Task Force for Clinical Trial Competency, a globally recognized standard used for certification and evaluation by numerous agencies, research centers, and companies.