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Nov 30, 2024
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2021-2022 Graduate Catalog This is not the most recent catalog version; be sure you are viewing the appropriate catalog year.
Clinical Research Administration [M.S.]
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Eastern Michigan University’s Clinical Research Administration MS Program is a two-year graduate program consisting of 34-35 credit hours. The program aims to facilitate the acquisition of knowledge, skills, attitudes, and abilities necessary to join and/or progress in the field of clinical research administration.
In recent years, there has been tremendous growth in pharmaceutical, biotechnology, and medical device research and development. In addition, collaborative initiatives between industry, academia, and the clinical research community have significantly expanded the opportunities for individuals to participate in the clinical research enterprise. To conduct the growing number of clinical research studies, there needs to be an expanded and better-qualified workforce that possesses the knowledge, skills, attitudes, and abilities necessary to coordinate and monitor clinical trials and manage data interfacing with the global 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:
- to provide an academic experience that includes both didactic information and optional hands-on preceptorships to provide qualified new personnel to the clinical research enterprise, and
- to provide an opportunity for professionals currently participating in clinical research and the drug/biologic/device development process to increase their knowledge base and their research/creative skills, to provide a pathway towards upward mobility in their professional careers.
Courses include the drug, biologic, vaccine and device development process, good clinical practice (GCP), Federal regulations and guidelines (The United States and international), clinical research protocol development, implementation, study start-up, management and close-out, study monitoring, research ethics, and research project or thesis.
Courses are offered in a hybrid (face-to-face and online) format to accommodate the nontraditional student and allow the student in full-time employment to complete courses while continuing to work.
EMU’s clinical research administration program is fortunate to have the support and collaboration of the following organizations: Henry Ford Health System, Karmanos Cancer Center, St. Joseph Mercy Hospital, University of Michigan Hospital, Michigan Institute for Clinical and Health Research, McLaren Healthcare, AstraZeneca This is a designated STEM (science, technology, engineering, and math) program.
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Program Admission
Requirements for Full Admission
Applicants must meet the minimum Graduate School admission requirements (see Graduate Admissions or International Admissions) and complete a Graduate Application.
Successful applicants to the Clinical Research Administration program will have demonstrated a sincere desire for a career focusing on clinical research and development. In addition, applicants must be fully aware of the differences in their career path from one in basic research, drug/biologic discovery research, or medical device invention.
Applicants must also meet the following program requirements:
- Earned a Bachelor 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.
- 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 coursework.
- Applicants should have excellent computer skills.
- Prior experience in a relevant industry is highly desirable but not required.
- Submit two letters of support
- Submit a statement of 500 words or more concerning career objectives.
Based on further documentation, the Program Director may waive any formal program requirements to consider other factors on a case-by-case basis. For example, work experience in a related field, life experience, fluency in multiple languages, or other cultural knowledge may be considered and prior academic performance.
This program admits new students for the Fall semester.
International Applicants
Applicants who possess a Bachelor’s degree from a post-secondary institution in a country where English is not the principal spoken language must satisfy one of the following tests of English language proficiency:
- TOEFL: 84 iBT
- IELTS: 6.5
- Pearson English Language Test (PTE): 58
Applicants who submit English Language Proficiency exam scores must also complete ESLN 565 if admitted.
Applicants should note that a high degree of proficiency in both written and oral communications in English is a fundamental skill required to complete the degree program and succeed 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/Advisor.
Advisor Information
Jean Rowan, MD, MS, 206E Marshall, 734.487.1238, jrowan3@emich.edu
Degree Requirements: 34-35 hours
Foundation Course in Statistics
For students entering the program without adequate knowledge of statistics, demonstrated by a grade of B or better in an acceptable undergraduate or graduate statistics course, a 3-credit 500-level (or above) course in statistics approved by the Program Director must be taken. Graduate Courses (500-level and above) taken as a deficiency course may count towards the student’s graduate degree as an elective. Undergraduate courses may not count towards a student’s graduate degree and will not appear on the student’s graduate transcript.
Required Courses: 19 hours
Track: 12 hours
Choose one of the following two tracks
Thesis or Project: 3-4 hours
Choose one option from the following
Typical Student Course Progression
Year One
Fall CLRA 510 and CLRA 520 (if required, ESLN 565 )
Winter CLRA 530 , CLRA 540 , and CLRA 581
Year Two
Clinical Trial Management Track
Summer Electives
Fall CLRA 601 and electives
Winter CLRA 575 , (CLRA 692 or 695 ), and electives
Regulatory Affairs Track
Summer CLRA 584 , CLRA 585
Fall CLRA 601 , CLRA 582 , and electives
Winter CLRA 575 , (CLRA 692 or 695 ), and electives
Note Students can take a maximum of 15 credit hours a semester
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