The Master of Science in Clinical Research Management is designed for experienced professionals working in academic research centers or private industry who seek greater depth and breadth of study in the science and business of clinical research.

This program is offered either mostly or fully online. Students entering the U.S. on an F-1 or J-1 Visa must enroll in a program full time. F-1 students are only permitted to enroll in one online course per semester and J-1 students may only enroll in non-credit online courses that do not count toward their degree program. WashU Continuing & Professional Studies (CAPS) cannot guarantee face-to-face enrollment options each semester of full time enrollment, therefore cannot issue an I-20 or DS 2019 to F-1 and J-1 students for this program. If you are an F-1 or J-1 student and wish to enroll in a CAPS program while here on a Visa, please contact our recruitment team to discuss your options for face-to-face program enrollment. F-1 and J-1 students should not enroll in online courses or programs without first consulting the university’s Office for International Students and Scholars (OISS).


Program Objectives

The Clinical Research Management graduate curriculum encompasses in-depth coverage of essential skills and processes required for the management of studies that develop drugs, devices and treatment protocols for patient care. Major topics include regulatory requirements, ethical issues, product development, the business of clinical research, grant funding and manuscripts, epidemiologic principles and tools, research design, and data analysis, all in the context of human subjects in clinical trials.

Who Should Apply?

Candidates for this master degree program typically hold or aspire toward leadership positions in academic research centers or related private sector organizations.

Likely candidates from academic research settings include clinical research investigators, coordinators, nurses, and sponsor representatives. Private sector candidates include pharmaceutical industry project managers, monitors, and regulatory affairs staff, as well as staff in community physician offices and independent research agencies.

Specific course work and overall program objectives for all clinical research management programs of study offered through WashU Continuing & Professional Studies (CAPS) reinforce the guidelines of “Good Clinical Practice” as outlined by the International Conference on Harmonization and adopted by the Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP).


24

Units of Required Courses

6

Units of Elective Requirements

Required Courses – 24 units

  • Fundamentals of Clinical Research Management (U80 500)
  • Advanced Data & Information Management in Health Sciences (U80 512)
  • Medical Writing for Clinical Research (U80 515)
  • Drug and Device Development (U80 518)
  • Compliance, Legal, and Regulatory Issues (U80 522)
  • Principles of Pharmaceutical Safety (U80 527) 
  • Leadership and Change in Health Care Services (U80 562)
  • Epidemiology for Clinical Research (U80 588)

Elective Requirements – 6 units

Authorized electives from Clinical Research Management or other appropriate graduate programs at WashU address individual interests such as device trials, ethics, and advanced research. Electives may include independent study.

Application Requirements

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