Post-Baccalaureate Certificate in Clinical Research

Certificate Level: Graduate
Admissions Requirements: Bachelor's degree or higher
Certificate Type: Post-Baccalaureate
Number of Credits to Completion: 15.0
Instructional Delivery: Online
Calendar Type: Semester
Expected Time to Completion: 1.5 years
Financial Aid Eligibility: Not aid eligible

Classification of Instructional Program (CIP) Code: 51.0719
Standard Occupational Classification (SOC) Code: 11-9111

About the Program

This part-time certificate program is a valuable professional resource for today's busy physicians, physician assistants, nurses, clinical fellows, research coordinators and other individuals working in the clinical arena who want in-depth exposure to the skills and knowledge needed in the evolving clinical research field without having to commit to an entire master’s program. All courses are conducted online to accommodate the needs of working professionals.

This program requires the successful completion of five graduate courses. Credits earned in the certificate program are recognized toward the Master of Science in Clinical Research Organization and Management.

Admission Requirements

A bachelor's degree from a regionally accredited institution in the United States or an equivalent international institution.

Cumulative GPA of 3.0 (graduate degree GPA will be considered along with the undergraduate GPA)

Required documents:

  • A completed application
  • Official transcripts from all universities, colleges and other post-secondary educational institutions (including trade schools) attended
  • Two letters of recommendation
  • Essay on your past successes, goals and objectives for pursuing this program
  • Resume
  • Additional requirements for international students

A telephone interview may be requested.

Additional Information

Robert Sterling, PhD
Director, Graduate Programs in Clinical Research

Visit the Drexel University Online website for more program information and to apply to the certificate program.

Program Requirements

CR 515SIntro to Clinical Trials3.0
CR 545SPharmaceutical Law3.0
CR 612SFundamentals of Compliance3.0
Electives *
Select two of the following:6.0
New Product Research and Development
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
Quality Assurance Audits
Ethics and Law
Ethical Issues in Research
The History of Misconduct in Biomedical Research
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 Credits15.0

Courses not listed above may be taken as electives only with the approval of the program director.

Sample Plan of Study

Term 1CreditsTerm 2CreditsTerm 3Credits
CR 515S3.0CR 612S3.0CR 545S3.0
 6 6 3
Total Credits 15
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