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Master of Science in Clinical Research Administration
EMU's Master of Science Program in Clinical Research Administration is designed to provide an opportunity for professionals participating in the drug/device development process to increase their knowledge base as well as their research/creative skills. The program creates a pathway for upward mobility in professional careers within the drug/device research and development industry.
Career Opportunities
During the past ten years, there has been tremendous growth in the expenditures for pharmaceutical research and development, made by both traditional pharmaceutical companies and by the emerging biotechnology industry. This growth has been fueled by many factors, including the emergence of new discoveries and manufacturing technologies, new drug therapies, the Human Genome project, high throughput screening and the need for new pharmaceuticals that has been generated by population growth and the aging of the "baby boom" generation. New drug discovery technologies have created a steady flow of clinically significant candidates for pharmaceutical products. The development process, which is highly regulated by the federal government, is complex and requires the skills of many health professionals.
It has been estimated that for every physician investigator, there are six support staff whose skills are essential to the development process that adds new drugs and devices to the marketplace. These staff include clinical coordinators, clinical monitors, data coordinators, project managers and regulatory affairs professionals. Currently, there is a significant shortage of individuals with an understanding of the drug/device development process. This shortage is expected to continue as the number, size and complexity of clinical studies on new chemical entities and biotechnology related products increases. Graduates of the clinical research administration program will have the knowledge base and the hands-on skills to help fill this need.
Program of Study
- CLRA 510 Introduction to Drug Development (3)
- CLRA 520 Clinical Study Management I (3)
- CLRA 530 Clinical Study Management II (3)
- CLRA 540 Advanced Topics in Clinical Research Administration (3)
- CLRA 601 Graduate Seminar in Clinical Research (1)
- CLRA 692/695 Special Project in Clinical Research Administration (3)
Elective Courses
- CLSC 501 Fundamentals of Epidemiology (3)
- CLRA 550 Preceptorship in Drug Development (3)
- CLRA 561 Legal Issues in Drug Development (2)
- CLRA 571 Grant and Contract Management for Research Project Administrators (3)
- CLRA 581 Regulatory Affairs and Drug Development (3)
- CLRA 582 Regulatory Affairs and Drug Development II (3)
- CLRA 583 Regulatory Affairs and Drug Development III (3)
- CLRA 590 Special Topics (1)
- CLRA 591 Special Topics (2)
- CLRA 592 Special Topics (3)
Cognate Elective Courses
- HLAD 511 Health Law (3)
- HLAD 510 Medical Care Organization (3)
- NURS 500 Advanced Pathophysiology (3)
- CHEM 414 Regulatory Toxicology (Graduate Level) (2)
- CHEM 515 Industrial and Environmental Chemistry (3)
- CHEM 555 Neurochemistry (3)
- CHEM 571 Advanced Organic Chemistry (3)
- BIOL 542 Molecular Genetics (3)
- OCTH 640 Research Methods (3)
- HLAD 512 Reimbursement for Health Care Services
- HLAD 520 Health Care Management Theory
- HLAD 521 Health Care Finance
- HLAD 524 Health Care Manager Strategies
- CLRA 597 Independent Study (1)
- CLRA 598 Independent Study (2)
- CLRA 599 Independent Study (3)
For More Information
Stephen A. Sonstein, Ph.D.
Director, Clinical Research Administration
Eastern Michigan University
206E Marshall Building
Ypsilanti, Michigan 48197
734.487.1238 | Fax: 734.487.4095
Read more information by downloading the fact sheet PDF.