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Clinical Research and Trials: Implementation

Qualified professionals are needed for clinical trials positions to meet the needs of rapidly expanding pharmaceutical and biotechnology industries. The Certificate Program in Clinical Research and Trials will provide the core competencies and skills needed by professionals in the field of clinical trials. The Program will train individuals in administration, coordination, and management of clinical research studies for the development of new drugs, medical devices, and treatment regimens. This certificate is complimentary to the Human Clinical Investigation: Theory.

The objectives of this certificate option are:

  • To introduce the roles and responsibilities of investigators and sponsors

  • To educate on the regulations governing clinical research

  • To train for the management of a clinical trial

Core Courses

GC 625 Drug Development
2 credits
GC 630 Fundamentals of Clinical Trials (GC 660 is pre-requisite)
3 credits

GC 635
GC 617

Fundamentals of Clinical Trial Management – OR –
Management of Pharmaceutical Drug Development Projects

2 credits
  2 credits

GC 660

Statistical Methods of Data Analysis

3 credits

Core Total
10 credits

Select 5 Credits from the Following *

GC 510

Database Design and Management

2 credits

GC 610

Strategic Management: Increasing R&D Productivity
by Creating Value

2 credits

GC 617 Management of Pharmaceutical Drug Development Projects
2 credits 

GC 640

Research Ethics and Responsible Conduct

1 credit

GC 650

Economic Analysis of Healthcare Interventions

3 credits

GC 670 Applied Regression Models
2 credits
GC 720 Scientific Writing
2 credits
Elective Total
5 credits
Certificate Total
15 credits

Who May Attend

Persons with scientific/medical background or experience who are interested in careers in clinical research. Persons who may benefit from University study in this program include study coordinators, clinical trial center staff, physicians, medical directors, biomedical scientists, research scientists, nurses and allied health professionals, statisticians, pharmacists, IRB monitors, and others seeking to enhance or develop their clinical and research skills. Pharmaceutical, biotechnology, device industry personnel who desire a career in clinical research may also find this program useful.

* Suggested electives. Other courses may be substituted upon approval

Further information


Please contact Eleanor Gorman, Assistant Coordinator for Master's Programs in the Basic Sciences, by e-mail or by telephone at 215 503-5799.




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