Revised Program, effective Fall 2013
In recent years, there has been tremendous growth in pharmaceutical and medical device research and development. This growth has been in the traditional pharmaceutical companies and in the emerging biotechnology industry. Many factors have fueled this expansion, including the emergence of new discovery 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. In 2009, a record $65 billion was invested in pharmaceutical research in the United States. In order to conduct this growing clinical research enterprise, there needs to be an expanded and better qualified workforce. This workforce must posses the knowledge, skills, attitudes and abilities necessary to accomplish the tasks of coordinating and monitoring clinical studies as well as managing data and interfacing with the regulatory agencies. Eastern Michigan University developed one of the first academic programs designed to produce individuals credentialed to function in the area of Clinical Research Administration and is now a national leader in the area.
The mission of EMU’s Clinical Research Administration Program is twofold: a) 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. This should provide a pathway for upward mobility in their professional careers within the drug/device research and development industry; b) to provide an academic experience which includes both didactic information and hands-on preceptorships in order to provide qualified new personnel to the drug development industry.
Toward this end, EMU has developed two interlinked programs. The Post-Baccalaureate Certificate in Clinical Research Administration consists of four courses which provide information concerning the drug development process, good clinical practice (GCP), federal regulations and guidelines (United States and international), clinical research protocol development, implementation and monitoring. Courses are offered in a format which suits the nontraditional student and allows the student with a full-time job to complete the courses while continuing to work. Upon satisfactory completion of the didactic component of the program, students may apply for admission into a hands-on preceptorship experience with contract research organizations, pharmaceutical firms and clinical facilities which collaborate with the program.
The Master’s degree in Clinical Research Administration is designed for individuals who are already employed in the industry and desire increased perspective and competency and a higher level of responsibility. The four required courses in the certificate program are supplemented with program electives, cognate electives and a project or thesis.
EMU’s clinical research administration program is fortunate to have the support and collaboration of the following organizations:
- Oakwood Hospital
- Borgess Research Institute
- Providence St. John Hospital
- University of Michigan Hospital
- University of Michigan Institute for Clinical and Health Research
- St. Joseph Mercy Hospital
- Karmanos Cancer Center
- Henry Ford Hospital
- ClinSite, Inc.
- KMED Research
Successful applicants to the Clinical Research Administration program will have demonstrated a sincere desire for a career with a focus on clinical research and development. Applicants must be fully aware of the differences in their career path from one in basic research, discovery research or device invention.
To be admitted applicants must have a Bachelors of Science or Arts. While previous studies in the sciences, engineering or health care are preferred applicants may come from a wide variety of undergraduate (or post graduate) areas of study including, but not limited to: nursing, pre-med, biology, chemistry, mathematics, science education, pharmacy, engineering, business, computer science, psychology, social sciences, pre-law, etc. Applicants with M.A., M.S., Ph.D., M.D., or J.D. degrees are encouraged to apply. Applicants should have excellent computer skills. Prior experience in a relevant industry is highly desirable.
Formal Requirements for Full Admission
To be fully accepted into the Clinical Research Administration program an applicant must:
Be a Baccalaureate graduate of an accredited four-year college or university;
Have a grade point average (GPA) of at least 3.0 (on a 4.0 scale) in the last 60 semester/90 quarter units of course work;
Applicants who do not possess a Bachelor’s degree from a post-secondary institution where English is the principal language of instruction must take and pass the TOEFL (Test of English as a Foreign Language) with a score of 84 or better; Catalog Correction: Students who enter the program with a TOEFL requirement must take ESLN 592 during the first semester of classes.
Submit 2 letters of support;
Submit a statement of 500 words or more concerning career objectives.
Applicants should note that a high degree of proficiency in both written and oral communications in English is a fundamental skill required both to successfully complete the degree program and for success in the field. Applicants who are unsure of their skill level in either spoken or written English are advised to consult with the program director. For those whose English language skills are not adequate for full admission there may be programs made available to enable full admission at a later date.
Based on further documentation, the Program Director may waive any of the formal requirements, other that the first above, to take into consideration other factors on a case-by-case basis. Work experience in a related field, life experience, fluency in multiple languages or other cultural knowledge may be considered as well as prior academic performance. Admission may be granted on a Conditional Basis with specific requirements that must be met prior to Full Admission.