Jun 17, 2019  
2016-2017 Graduate Catalog 
    
2016-2017 Graduate Catalog THIS IS NOT THE CURRENT CATALOG. LINKS AND CONTENT ARE OUT OF DATE!

Master of Science in Clinical Research Administration (CRAD)


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. 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 growth and the aging of the “baby boom” generation. In 2013, a record $85 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 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 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 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 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’s degree 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.

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
  • Trialynx, Inc.
  • University of Michigan Hospital
  • University of Michigan Institute for Clinical and Health Research

Admission Requirements:


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 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.

Formal Requirements for Full Admission

To be fully accepted into the Clinical Research Administration program an applicant must:

  1. Be a Baccalaureate graduate of an accredited four-year college or university;
  2. 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;
  3. 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; students who enter the program with a TOEFL requirement must take ESLN 565  during the first semester of classes.
  4. Submit 2 letters of support;
  5. 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 prior to 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 during the Fall semester.

School Information:


School of Health Sciences - College of Health and Human Services

Colleen Croxall, Ph.D.
Director

313 Marshall
(734) 487-4096
ccroxall@emich.edu

School Website

Advisor Information:


Stephen Sonstein, Ph.D.

206E Marshall
(734) 487-1238
ssonstein@emich.edu

Degree Requirements: 34-35 hours


Thesis or Project: 3-4 hours


Choose one option from the following:

Option I - Thesis:


Choose a minimum of three hours from the following:

Option II - Project:


Choose either three or four hours from the following:

Typical Student Course Progression


Note: Students can take a maximum of 15 credit hours a semester

Fall One Winter One Summer Fall Two Winter Two

CLRA 510 

CLRA 520 

*ESLN 565 

CLRA 530

CLRA 540

CLRA 581 

CLRA 550 

or

elective

CLRA 601

CLRA 685

CLRA 582

CLRA 583 or 561

Other electives

CLRA 575

CLRA 692 or 695

Other electives

*if required