Jul 03, 2022  
2022-2023 Graduate Catalog [Working Draft] 
    
2022-2023 Graduate Catalog [Working Draft]

Clinical Research Administration [M.S.]


Revised Program [Fall 2022]


Eastern Michigan University’s Clinical Research Administration MS Program is a two-year graduate program with 34-35 credit hours. The program aims to facilitate the acquisition of knowledge, skills, attitudes, and abilities necessary to join and progress in 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 extended 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:

  1. 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
  2. to provide an opportunity for professionals currently participating in clinical research and the drug/biologic/device development process to increase their knowledge base and research/creative skills and 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 classes 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 SystemKarmanos Cancer Center, St. Joseph Mercy HospitalUniversity of Michigan HospitalMichigan Institute for Clinical and Health ResearchMcLaren HealthcareAstraZeneca 

This is a designated STEM program (See OPT Extention).

 

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.

School Information


Health Sciences 313 Marshall, 734.487.4096

Colleen Croxall, PhD, Director 

Advisor Information


Jean Rowan, MD, MS, 206E Marshall, 734.487.1238

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.

Degree Requirements: 34-35 hours


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

Summer Electives

Fall CLRA 601  and electives

Winter CLRA 575 , (CLRA 692  or 695 ), and electives

 

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

Critical Graduation Information


Each graduate student is responsible for fulfilling the requirements or their equivalents of the Eastern Michigan University catalog in force at the time of their initial registration or a subsequent catalog, including the one in effect at the time of their graduation.

Master’s degree requirements must be completed within six (6) years of first enrollment in the master’s degree program.

In the event a student does not complete the master’s degree requirements within six years of the date of their original registration, the student may be required to have their credits re-evaluated by the academic department(s) of their degree in keeping with catalog requirements in force during the year of their graduation.

The following are minimum requirements for all master’s degrees awarded by Eastern Michigan University. Some programs require more than the minimum in one or more areas below.

  • A master’s degree must require a minimum of 30 credit hours.
  • No more than six credits of independent study courses, and no more than 12 credit hours of special topics and independent study courses combined, may be applied to a graduate degree.  
  • Residency Requirement:
    • For students admitted to master’s degree programs of 36 or fewer required hours, at least 24 new graduate hours beginning the semester of acceptance and enrollment into the degree program must be earned at EMU. The remaining program requirement hours may be met through transfer or prior degree credit (EMU or elsewhere). 
    • For students admitted to master’s degree programs of 37 or more required hours, at least 30 new graduate hours beginning the semester of acceptance and enrollment into the degree program must be earned at EMU. Minimum degree hours must still be met for graduation. The remaining program requirement hours may be met through transfer or prior degree credit (EMU or elsewhere).
    • Residency and enrollment in multiple programs: Students enrolled in multiple master’s/specialist degree programs must have 24 unique credit hours in each degree program.
  • Only credits from one completed graduate certificate may be applied to a master’s or specialist degree in a relevant field of study, as determined by the Graduate School and with the approval of the degree-granting academic department, and be included in the residency hours above.
  • Students must maintain a 3.0 cumulative GPA in all graduate-level courses taken at EMU and in their program of study to remain in good academic standing and be eligible for graduation. Students do not need to be registered for classes during the semester of graduation.
  • The Graduate School does not permit the use of undergraduate courses (499 and below) to meet degree requirements on graduate programs of study.
  • Some master’s programs require a thesis; others require a special project or internship; others require students to pass a final exam. See the Graduate School website for Thesis and Dissertation Manuals, all forms, and information about research and human subject approval. Every completed thesis or dissertation must be submitted to Digital Commons. Any form of graduate student work submitted to Digital Commons must first be approved by a faculty advisor and the Graduate School.