Master's degrees are gaining acceptance

Industry changes require more education

Master's degree programs in clinical research administration or management, as well as certificate programs, are gaining ground as training vehicles for people who work in health care or another professional field and would like to switch to clinical trials and research.

The pioneering clinical research administration program at Eastern Michigan University in Ypsilanti, MI (www.emich.edu/hs/cra), is only a decade old, and one of the first master's degree programs for nurses specializing in clinical research management at Duke University School of Nursing (http://www.nursing.duke.edu/page/crm_home) in Durham, NC, is just seven years old. Both institutions also offer a non-traditional track in which students can obtain a certificate after completing clinical research curriculum.

Duke started the clinical research management degree because administrators perceived a need for research training within the Research Triangle Park community, says Elizabeth E. Hill, RN, MS, DNSc, assistant professor and director of the clinical research management specialty. Hill is also on the editorial board of Clinical Trials Administrator.

"We're the only group in the school of nursing where we have something where we admit people who aren't nurses," Hill notes. "We offer a post-graduate certificate for people who have at least a master's degree in some other field, but who want to get into clinical trials."

Advanced education in clinical research is becoming more widely available at a time when the clinical trial job market is booming.

"The job market's phenomenal right now," says Stephen Sonstein, PhD, director of clinical research administration program for Eastern Michigan University. "Clinical trials are getting larger, there are more of them, and they are more complex; the graduates of our programs have the depth of knowledge necessary to deal with this level of change."

Previously, clinical trials staff would gain experience on the job, often moving into the field of research by more luck than design, he says.

"In the past, people became clinical trial managers or clinical research associates on an ad hoc basis, by being in the right place at the right time," Sonstein says. "They had the skills and trained on the job."

These degree programs in clinical research developed because this is the traditional way people in health-related professions become qualified entry level professionals, and clinical research has become as specialized as any of the other medical fields, he adds.

Sonstein estimates there are about 35 clinical research administration degree programs in the United States and perhaps 100 world-wide.

"With everything going on with clinical trial regulatory issues and the growth of drug companies, clinical research administration no longer is a job where you can learn on the job," Hill notes. "You need an education just like you do with other specialties."

Even clinical trial professionals who are experienced find it difficult to keep up with the changing regulations and requirements, as well as stay ahead of industry shifts and outsourcing trends, Hill says.

"There is a base of knowledge you need to really become an expert in managing clinical trials," she adds. "So this program gives graduates the well-rounded education they need to start out well ahead of the other research professionals who have on-the-job training."

Duke clinical research graduates have gone on to have residencies with the FDA and have been hired by contract research organizations, she notes.

As universities increasingly add clinical research degrees programs, the industry is beginning to accept these degrees and/or certificates as proof of entry-level job qualification, Sonstein notes.

Job hunters who have earned either the university's master's degree in science, clinical research administration, or the post-baccalaureate certificate in clinical research typically can find good jobs after completing the program, Hill and Sonstein say.

"It's taken us a little while to demonstrate to people, but now I think it's definitely helping people get jobs," Hill says. "What we're really trying to show people is how people who have this master's degree don't have to start out in the hospital as a clinical research coordinator and can start out at an advanced level."

Duke's master's program is for nurses and provides 39 credits for an MSN degree in clinical research, and students complete a 200 hour residency; the post-graduate certificate program involves 19 credits, Hill says.

Duke's post-graduate certificate and Eastern Michigan's post-baccalaureate certificate programs have attracted students from a variety of backgrounds, including lawyers, veterinarians, statisticians, and even physicians who received their doctorates in foreign nations, such as China, Hill and Sonstein say.

"We've had a lot of people who were medical doctors in China, but who aren't qualified to take the boards here," Hill says. "They want to stay in the medical arena and have gotten the post-graduate certificate."

The master's degree in clinical research administration at Eastern Michigan has attracted dietitians, medical technologists, and others in health care, as well as nurses, Sonstein says.

"People come into this program when they want to transition into a different kind of health care profession," Sonstein explains. "They may be burned out or lost their job, but they want to use their skills in another profession, and this program has provided them with the opportunity."

Others entering the master's degree program are bench researchers who had worked in research labs and now want to move into clinical trial work, Sonstein says.

"The third group is foreign physicians who came to this country with skills, but cannot practice their profession because of the regulations here, and this gives them an opportunity to get a good job utilizing their skills in this country," Sonstein adds.

The Eastern Michigan master's program involves two to 2.5 years of study and a master's thesis or research project, and the post-baccalaureate certificate program can be completed within one year, Sonstein says. The certificate program includes coursework and a hands-on preceptorship. "The post-baccalaureate certificate program provides entry-level competencies for a person entering the field," Sonstein says.

Sonstein is part of a group of university administrators who run clinical research programs and who have been meeting on a casual basis for the past six or seven years.

"We decided in 2002 to formalize this group and we received support from the Philadelphia-based Drug Information Association and created the Consortium of Academic Programs in Clinical Research," Sonstein says. "We meet annually at DIA meetings, and the purpose of the group is to discuss common issues."

The group wants to define the knowledge base that entails a clinical research administration degree and to analyze content competencies and work toward programmatic accreditation, Sonstein adds.