Clinical Research Organization and Management

Major: Clinical Research Organization and Management
Degree Awarded: Master of Science (MS)
Calendar Type: Semester
Minimum Required Credits: 36.0
Classification of Instructional Programs (CIP) code: 51.0000
Standard Occupational Classification (SOC) code:

About the Program

The Master of Science in Clinical Research Organization and Management is an online program designed 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
  • 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

Kamran Mohiuddin, M.D., M.B.A.,FAPCR
Director, Graduate Programs in Clinical Research

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

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

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 and 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
Intro to Clinical Trials
Scientific Writing and Medical Literature
Designing the Clinical Trial
Innovative Product Development
Introduction to Clinical Pharmacology
Regulatory, Scientific and Social Issues Affecting Biotech Research
Compliance and Safety Surveillance
Compliance & Monitoring Issues
Principles and Practice of Pharmacovigilance
Fundamentals of Compliance
Quality Assurance Audits
Ethics and Law
Ethical Issues in Research
The History of Misconduct in Biomedical Research
Pharmaceutical Law
Contemporary Issues in Human Research Protection
Healthcare Inequities in Biomedical Research
Emerging Trends in Medical Device Regulation
Medical Device Combination Product Regulation
World Wide Regulatory Submissions
Current Issues in Review Boards
Current Federal Regulatory Issues in Biomedical Research
International Regulatory Affairs
Patient Generated Data in Clinical Research
Biostatistics and Data Management
Applications of Clinical Research Biostatistics
Clinical Data Management
Health Information Technology in Biomedical R&D
Applications of Clinical Research Biostatistics II
Clinical Research Management
Sponsored Projects Finance
Fundamentals of Academic Research Administration
Clinical Project Management
Patient Recruitment and Informed consent
Leadership Skills
Risk Management in Clinical Research
New Therapeutic Product Business and Strategic Planning
Business Processes and Contemporary Concerns in Pharmaceutical R & D
Clinical Trial Budgeting
Clinical Outsourcing
Informatics in Pharm Res & Development
Health Policy and Economics
Strategic Planning
Total Credits36.0

Sample Plan of Study

First Year
Program Requirements6.0Program Requirements6.0
 6 6
Second Year
Program Requirements6.0Program Requirements6.0
 6 6
Third Year
Program Requirements6.0Program Requirements6.0
 6 6
Total Credits 36
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