In recent years, there has been tremendous growth in pharmaceutical and medical device research and development. This growth has been both in the traditional pharmaceutical companies and in the emerging biotechnology industry. Collaborative initiatives between industry, academia and the clinical community have significantly expanded the opportunities for individuals to participate in the clinical research enterprise. 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 techniques, as well as growth and the aging of the “baby-boom” generation. In 2015, over $100 billion was invested in medicines and medical device 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 possess 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 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: a) to provide an academic experience which includes both didactic information and hands-on preceptorships in order to provide qualified new personnel to the drug and device development industry and b) to provide an opportunity for professionals currently 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. 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 and device development process, good clinical practice (GCP), Federal regulations and guidelines (The United States and international), clinical research protocol development, implementation, and monitoring. Courses are offered in a hybrid (face-to-face and online) 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 of Science in Clinical Research Administration is designed for individuals who are already employed or credentialed in the medicines, or device development field 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. Students may focus their program to credential them for employment opportunities in Clinical Trial Management (CTM) or Regulatory Affairs (RA) or both through the selection of appropriate electives and specialized preceptorship opportunities.
EMU’s clinical research administration program is fortunate to have the support and collaboration of the following organizations: Borgess Research Institute | ClinSite, Inc. | Henry Ford Hospital | Karmanos Cancer Center | MMS Holdings | Providence St. Johns Hospital | St. Joseph Mercy Hospital | University of Michigan Hospital | Michigan Institute for Clinical and Health Research
This is a designated STEM (science, technology, engineering, and math) program.
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 Bachelor’s 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, but not required.
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; Applicants who possess a Bachelor’s degree from a post-secondary institution in country where English is not the principal spoken language must take and pass the TOEFL (Test of English as a Foreign Language) with a score of 84 or better; students who enter the program with a TOEFL requirement must take ESLN 565 during the first semester of classes.
- 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;
- Submit two 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, but whose academic credentials are outstanding may be granted Conditional Admission with specific criteria which must be met before Full Admission.
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.
This program admits new students for the Fall semester.
Jean Rowan, MD, MS, 206E Marshall, 734.487.1238, firstname.lastname@example.org
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
Fall CLRA 510 and CLRA 520 (if required, ESLN 565 )
Winter CLRA 530 , CLRA 540 , and CLRA 581
Clinical Trial Management Track
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