Clinical Research Going Strong

The industry depends heavily on research professionals, such as clinical research coordinators, to keep the trials of new drugs and medical devices running smoothly. The new-drug development process usually has three phases. Earlier phases may take months; later ones could span several years. Coordinators follow strict guidelines in tracking how patients tolerate and respond to the medication.

"There is a very big demand in our market," said Betsy Stein, director of clinical research at Baylor Research Institute, part of Baylor Health Care System. Working under the supervision of a physician investigator, a coordinator informs potential trial participants about what will take place and leaves it up to them to decide whether to enroll in the study. The coordinator also facilitates the timeliness of office visits, assessments and lab tests.

"They play a very important role in patient safety - being a patient advocate and being sure that regulatory compliance is met," said Ms. Stein, who has a bachelor's degree in biology and has worked at Baylor for 24 years since college graduation. Coordinators work for academic medical centers, clinical research organizations, pharmaceutical companies large and small and physicians who conduct trials.

"Many of our students are hired by the site where they do their internships," with starting salaries between $50,000 and $80,000, said Patricia Gwirtz, assistant dean and professor of integrative physiology at the Graduate School of Biomedical Sciences at the University of North Texas Health Science Center. The school offers a master's degree in clinical research management.

"Our students have been very successful in getting positions after graduation. Also, many of our students go on to medical school since their goal is to conduct clinical research as a physician," said Dr. Gwirtz, who holds a doctorate in physiology. "Their reason for joining our program first is to gain the knowledge about clinical research, which is not part of the medical curriculum." With the demand for coordinators increasing every year along with the surge in clinical research, most clinicians prefer to rely on someone who is familiar with the regulations. This frees up the doctors to concentrate on providing care to patients enrolled in the trial and others.

Universities and hospitals typically seek individuals with at least an associate degree in nursing or another scientific discipline. "But there are extremely good, qualified, certified study coordinators who do not have degrees," said Dr. Anderson, who has a master's in nursing and a doctorate in philosophy. "You then have physicians serving as study coordinators in some cases. The range of experience, education, certification will directly correlate with job responsibilities."

Experience is weighed as heavily as education in the certification process, Dr. Anderson said. To excel in this role, coordinators must be detail-oriented workers who capture and report data accurately. They occasionally may have to work extended hours and be on call evenings and weekends. These specialists not only recruit patients for a particular study but also represent the company to the U.S. Food and Drug Administration and regulatory agencies in other countries. Others advise the company on drug manufacturing according to the FDA's specifications.

Study or protocol coordinators are usually entry-level positions, with opportunities to advance to study managers and perhaps associate directors, generating six figures. The more junior person could look at opportunities in the mid-40s. The more senior person could look at opportunities in the high 70s.

Two organizations offer certifications, they are the Association of Clinical Research Professionals and the Society of Clinical Research Associates.

Source: Dallas Morning News, Susan Kreimer, 1/13/8