Entry level clinical research jobs and core competencies

Expert explains why link must be forged

The traditional model based on mentorship in the clinical research profession now is being replaced by formal education through academic institutions.

"There have been an increasing number of academic educational programs developed over the past 10 years or so, covering the disciplines, which compose the clinical research enterprise," says Stephen A. Sonstein, PhD, director of clinical research administration at Eastern Michigan University in Ypsilanti, MI.

"Basically, what is happening in clinical research is that it is becoming an academic discipline," Sonstein says. "And like any other academic discipline, there are basic knowledge bases that the discipline covers."

The old model of people becoming clinical research coordinators because they seem to have the appropriate skills and happen to be in the right place at the right time doesn't work in today's more complex CR field, Sonstein notes.

"There isn't a lot of time and financial flexibility to allow a person to be a mentor to a new CR associate," he says. "It is important to come to the job with some understanding and, hopefully, some experience."

As with any other health-related profession, there is a need for the clinical research profession to define its core competencies for entry level and advanced level clinical research positions, Sonstein says.

This is one of the tasks which have been taken up by a six-year-old group called the Consortium of Academic Programs in Clinical Research [www.coapcr.org], Sonstein says.

The consortium is comprised of directors of academic programs that produce CR professionals, as well as representatives from clinical facilities that support those programs.

The group meets annually at the same time as the Drug Information Association's (DIA's) annual meeting. DIA has helped facilitate the development of the group, Sonstein says.

"We're working on a white paper on the topic, and we're trying to get as much participation as possible," Sonstein says. "We're trying to get input from the hiring authorities on the clinical and sponsor side to say what it is they want to see in people who graduate from our academic CR programs."

For instance, they're asking hiring authorities questions like the following:

  • What kinds of skills should an entry-level CR professional have?
  • What do you mean when you require two-to-five years experience? Is it just time in the job or do you require documentation of high quality ability?
  • What different competencies are needed for a CR professional who has an associate's degree, a bachelor's degree, or a master's degree?

This process of developing competencies has already occurred for the health professions, such as nursing or medical technology, which have been in existence for decades, Sonstein notes.

"The nursing profession has defined what is required in an entry level profession and this has determined which competencies should be included in an academic program," he says.

"Nursing organizations inspect the academic programs that want to be recognized and accredited," he explains. "Our long-term goal is to develop an accrediting body for academic programs in clinical research, and the beginning of the process is to define the core competencies."

Any competencies white paper developed by the consortium will need to obtain buy-in from the people who hire entry-level CR professionals, Sonstein says. "This is a new concept for clinical research, but it's a concept whose time has arrived," he notes.