I recently struck up a conversation at a social event with Irwin Martin, PhD, who is now a professor in the Clinical Research Administration Program at Eastern Michigan University in Ypsilanti, MI. He has a background as an executive in the pharmaceutical industry. We discussed EMU's program to train personnel for positions as clinical research administrators. Some of the readers of Lab Soft News might benefit from hearing about it. Below is an excerpt from a document he sent to me:
Clinical research in the US and around the world continues to expand. Studies are being conducted by multinational drug and medical devices companies as well as in many medical centers around the world. There are many employers looking to fill open positions with trained professionals. Eastern Michigan University in Ypsilanti, MI, offers training to individuals with a BA or BS degree and an aptitude for science. The mission of EMU’s Clinical Research Administration Program is to provide an academic experience which includes both didactic information and hands-on preceptorships that provide qualified new personnel to the drug and device development industry and 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 training 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..., [and] clinical research protocol development, implementation, and monitoring.....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 research project or thesis. Students may focus their program to prepare them for employment opportunities in Clinical Trial Management or Regulatory Affairs or both through the selection of appropriate electives and specialized preceptorship opportunities.
Because of the centrality and constant expansion of clinical research and clinical trials in both academic institutions and the pharmaceutical industry, there is continuing need for administrative personnel to help manage drug and medical device clinical trials. Salaries are attractive and work settings vary. My work on an IRB at a medical school reinforced in my mind the criticality of these personnel. I have always been impressed by their talent and enthusiasm. Take a look at the EMU program if interested or those at other universities.