Clinical Research Organization and Management

Major: Clinical Research Organization and Management
Degree Awarded: Master of Science (MS)
Calendar Type: Semester
Total Credit Hours: 36.0
Classification of Instructional Programs (CIP) code: 51.0000
Standard Occupational Classification (SOC) code:
11-9199

About the Program

The Master of Science in Clinical Research Organization and Management is an online program designed both for individuals already trained in the area of clinical sciences, as well as for others who desire a focused education in the proper conduct of clinical research.

The Master of Science in Clinical Research Organization and Management program offers students a rigorous graduate education taught by leaders from the pharmaceutical, biotechnology and medical device industries, as well as from academic research centers. The program provides online courses that include scientific rationale related to the design and analysis of clinical trials, epidemiology and biostatistics, ethics-based reasoning for the conduct of research, clinical trial management and monitoring processes, and federal regulatory rules and policies essential to the development of a broadly-educated and well-prepared professional in clinical research and new therapeutic product investigation.

The program is designed so that graduates will be able to:

  • Successfully apply the framework and philosophies of research to the management of clinical trials, employing quality principles of current good clinical practice to produce valid and useful data;
  • Ensure that sound ethical principles and values are always recognized and upheld in research involving a human population;
  • Use current statistical knowledge and methods in the design, implementation, conduct, and assessment of clinical trial programs; and
  • Describe the scientific and clinical research literature to effectively interpret the results of clinical research, thereby enhancing the decision-making process.

Students work with advisors to customize their course plans to meet their career goals.

Program Delivery Options

All Clinical Research (CR) courses are offered solely online. Visit Drexel University Online for details.

Additional Information

Richard Mangano, PhD
Director, Graduate Programs in Clinical Research
richard.mangano@drexelmed.edu
215-762-3812

For more information about the program, visit the Master of Science in Clinical Research Organization and Management page on the Drexel University Online site.

For information about applying to the program, visit the Drexel University Online Admissions Criteria web page.

Degree Requirements

The Master of Science in Clinical Research Organization and Management program consists of 12 courses (36.0 credits). Any courses offered by the Clinical Research Organization Management program (Subject code "CR") may be applied to fulfill the requirements of this major. No master's thesis is required.

The program is organized into five areas of study devoted to clinical research and related administrative and regulatory issues. Students may take courses within their preferred area of study, a cross-section of courses within other areas of study, or any other Clinical Research (CR) courses being offered.

Program Requirements36.0
New Product Research and Development
Pharmaceutical R&D: Business Process and Information Flow
World Wide Regulatory Submissions
Intro to Clinical Trials
Innovative Product Development
Biotech/Research
Regulatory Compliance, Ethics and Law
Ethical Issues in Research
The History of Misconduct in Biomedical Research
Current Federal Regulatory Issues in Biomedical Research
Pharmaceutical Law
Compliance & Monitoring Issues
Contemporary Issues in Human Research Protection
Quality Assurance Audits
Fundamentals of Compliance
Biostatistics and Data Management
Epidemiology
Applications of Clinical Research Biostatistics
Designing the Clinical Trial
Clinical Research Management and Safety Surveillance
Fundamentals of Academic Research Administration
Scientific Writing and Medical Literature
Health Policy and Economics
New Therapeutic Product Business and Strategic Planning
Tech Transfer
Leadership Skills
Strategic Planning
Total Credits36.0
  • Schedule of Classes
  • All Course Descriptions
  • Co-op
  • Academic Advising
  • Admissions
  • Tuition & Fees
LEARN MORE