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
rcs336@drexel.edu
267.359.2310
Visit the Drexel University Online website for more program information and to apply to the certificate program.
Program Requirements
| Requirements | ||
| CR 515S | Intro to Clinical Trials | 3.0 |
| CR 545S | Pharmaceutical Law | 3.0 |
| CR 612S | Fundamentals of Compliance | 3.0 |
| 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 | ||
| Regulatory | ||
| 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 | ||
| Epidemiology | ||
| 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 Credits | 15.0 | |
- *
Courses not listed above may be taken as electives only with the approval of the program director.
Sample Plan of Study
| Term 1 | Credits | Term 2 | Credits | Term 3 | Credits |
|---|---|---|---|---|---|
| CR 515S | 3.0 | CR 612S | 3.0 | CR 545S | 3.0 |
| Elective | 3.0 | Elective | 3.0 | ||
| 6 | 6 | 3 | |||
| Total Credits 15 | |||||
