Multiple Opportunities

Conduct Clinical Trials Clinical trials, an important step in drug development, require a diverse team of people to plan, conduct, monitor, analyze, and write about the detailed, multistep testing of new drugs in humans. For each of these functions, there are promising opportunities for anyone who has a solid life science or health care background, a "detail" orientation, and good interpersonal skills. Available positions on these trials include project managers, medical investigators and study coordinators, clinical research associates, data managers and biostatisticians, and medical writers. THINK FAST: Tim Warneke says clinical trials need people who are quick learners. Experience with any aspect of the drug-development process makes a candidate for a clinical research position more desirable, according to scientists who do this type of work. In addition, "a key to this industry is to be a quick learner," says Tim Warneke, an associate clinical scientist with Quintiles Transnational Corp., a contract research organization (CRO) based in Research Triangle Park, N.C., that conducts clinical trials for pharmaceutical and biotechnology companies. Warneke notes that organizations conducting clinical trials are looking particularly for scientists with a facility for working with protocols, the detailed procedures used in a trial to test a drug's safety and efficacy. Specifically, he points out, successful candidates need to grasp what the trial should teach the company about the drug being tested and the kinds of difficulties to anticipate. "You have to be able to pick up a protocol [and] be able to read it and understand it," he stresses. The ability to quickly understand procedures is also valuable because so much of the knowledge and skills required of clinical-trial researchers are learned on the job. "There aren't good core curricula [in universities] out there that prepare people for these types of positions, so we try to find people with the right kind of raw material," reports Susan Thornton, senior vice president at IBRD-Rostrum Global Inc., a CRO with 500 employees and facilities in Africa, Europe, Japan, and the United States. Bachelor's or master's degrees in biology, chemistry, medical technology, nursing, and pharmacy are all likely to provide skills that clinical research managers seek, they say. According to the latest figures published by the Food and Drug Administration (FDA), drug and biotech firms filed 3,522 applications to begin clinical tests of new drugs from 1984 to 1993. In this decade, according to FDA, that rate has hit just over one new trial application filed for every day of the year. Clinical-Trial Research Resources American Association of Pharmaceutical Scientists (AAPS) 1650 King St., Alexandria, Va. 22314-2747 (703) 548-3000 Fax: (703) 684-7349 Internet: membership@aaps.org World Wide Web: http://www.cpb.uokhsc.edu/aaps/ 6,600 members President: Vincent H.L. Lee, Ph.D. AAPS's members are from academia, industry, government, and other private and public institutions. The organization fosters education and career growth; promotes the economic vitality of the pharmaceutical sciences and scientists; and works to influence public policy on health issues on behalf of its members. Associates of Clinical Pharmacology (ACP) 1012 14th St., N.W., Washington, D.C. 20005 (202) 737-8100 Fax: (202) 737-8101 5,200 members Executive Vice President: Frederic Harwood ACP aims to advance the development of professionals who conduct clinical research on drugs, biologics, and medical devices. Drug Information Association (DIA) 321 Norristown Rd., Suite 225, Ambler, Pa. 19002-2755 (215) 628-2288 Fax: (215) 641-1229 In Europe: DIA, Postfach 4012, Basel, Switzerland Phone: 41 61 382 90 19 Fax: 41 61 382 90 50 World Wide Web: http://www.diahome.org 13,000 members Executive Director: Erich Lukas (J. Robert Assenzo beginning in July 1996) DIA is an independent, nonprofit international scientific association composed primarily of professionals from the international pharmaceutical industry, regulatory agencies, and academia, including scientists involved in clinical research and testing. As each new clinical trial is started, a project manager from the drug company, biotech firm, or CRO conducting the trial is identified. Typically, the project manager selects the clinical sites, guides the preparation of the protocol, and has general oversight over all aspects of the clinical study, explains Thornton. "What we look for in project managers is some drug-development experience in the pharmaceutical industry," she notes. One or more clinical research associates (CRAs)-people like Warneke-are assigned to the project to assist with the preparation of the testing protocol. CRAs also recruit medical investigators, the physicians who will administer the test drug and conduct the clinical evaluation of its safety and effectiveness. Throughout the clinical trial, CRAs are the chief contact between the drug manufacturer and clinic site personnel, according to Rosina Maar, vice president for clinical operations at Quintiles. The CRAs also train personnel at each clinical site in the trial protocol. During return visits, the CRA monitors compliance with the procedures and checks that the data collected are recorded accurately. Maar says that CRAs, especially early in their careers, can spend as much as 80 percent of their time in the field. The entry qualifications for a CRA position are similar to those for a project manager, with somewhat greater emphasis on experience in a health-care setting. Maar says Quintiles looks for a four-year science degree in people first breaking into CRA work, although the company has hired people with two-year science degrees or even liberal arts degrees if they have experience in hospital work. IBRD-Rostrum favors an R.N. degree for this job, according to Thornton. Each clinical site also has a "study coordinator," who is responsible for administrative and data-collection tasks, states Richard D'Agostino, founder of RJD Associates, a San Rafael, Calif.-based drug-development and clinical-trials consulting firm. D'Agostino established RJD Associates last January after spending 36 years in the pharmaceutical industry. Physicians and their study coordinators rarely are employees of the drug or biotech company conducting the trials. Instead, they usually are from a private practice, a hospital, or an academic medical position, which provides them with access to a patient pool appropriate to the study. Warneke started his career in clinical research as a study coordinator in a cardiovascular research laboratory at Northwestern University. "I implemented protocols on site with the investigator, collecting data [and] building the source documentation to transfer to a case report," says Warneke, who holds a master's degree in exercise physiology. His days were filled seeing patients, interviewing them about their experience with the therapy being tested. At all levels in the clinical-trial network, Warneke adds, attention to detail is "what it's all about." For instance, when he was based in Chicago as a "traveling" CRA for Ciba Pharmaceuticals of Summit, N.J., a big part of his duties involved comparing information on the medical charts of participating patients with the data recorded on the case report forms that eventually would be sent to the company for the statistical analysis of the trial. 'PEOPLE' SKILLS: Debbie Moore Pettus notes the need to exercise diplomacy. Debbie Moore Pettus, another Quintiles CRA, says that success in this career also calls for good interpersonal skills. "You need to present yourself as organized, have good communication skills, and be able to deal with different personalities," she says. "And you need diplomacy, because you will encounter people who will give you a hard time." For instance, a doctor or study coordinator at a site might not agree with some aspect of the trial's protocol, or a study coordinator may not take sufficient care in screening patients for the health characteristics appropriate to the trial. The CRA needs to impress upon the clinic personnel to stick to the protocol; otherwise, the company risks getting unreliable data from that site-a costly error that could invalidate the entire trial if too few qualified subjects are included in the data analysis. Once data collection at the clinical sites ends, the analysis begins. "This requires a different skill set," from that needed in project managers and CRAs, says Thornton, although it still helps to have a biomedical or biological background. At this point, a data coordinator uses software and systems skills to program computers to catalog and manipulate the hundreds or thousands of patient experiences recorded during the clinical trial. Then a biostatistician, usually with an M.S. or Ph.D. degree, brings analytical skills to bear on the data. With the analysis complete, a medical writer assembles all of the information about the clinical trial into a final report. If the drug being tested proves to be a successful and safe therapy, then a writer will tackle the New Drug Application, the report filed with FDA requesting approval to market the new drug. These documents often run more than 1,000 pages and contain complete chemical information about the drug, how it is manufactured, and its pharmacodynamic and related properties, as well as results of the clinical testing. WHERE THE JOBS ARE: Leonard Rosenberg says CROs have the most available positions. "Medical writing is usually handled by someone with a Ph.D. who understands the science and has strong communication skills," remarks Leonard Rosenberg, senior vice president at SCIREX Corp., a CRO headquartered in Hartford, Conn. Officials at other companies, however, note that writers with an understanding of the drug-development process may need only a master's degree to qualify for this kind of work. Opportunities for researchers to advance, or change companies or location abound as spending on clinical trials increases. A recent survey conducted by the Pharmaceutical Research and Manufacturers of America (PhRMA), a Washington, D.C.-based trade group, found that the 100 largest U.S. drug and biotech companies spent $3.1 billion in 1994 for clinical trials, up 63 percent from the $1.9 billion spent in 1990. Employers who run clinical trials vary from traditional pharmaceutical companies, to biotechnology firms, to the growing number of CROs (M.E. Watanabe, The Scientist, Dec. 11, 1995, page 1). CROs now provide the most openings in this field, notes SCIREX Corp.'s Rosenberg. He says drug companies are "outsourcing" more of their clinical trials to CROs while maintaining internal clinical staff at nearly steady levels. Pay scales for those working in clinical trials vary because the background and experience of the people filling the positions vary so much, according to directors of CROs. In general, project managers, CRAs, data coordinators, and those in related positions can start in the upper $30,000s, although with the right mixture of knowledge and experience, some people can command starting salaries closer to $50,000. Biostatisticians or others with Ph.D. degrees germane to their duties might earn a little more. In addition to advancement opportunities, job security, and good salaries, a career in clinical trials provides a "tremendous opportunity to have an active, visible role in the conduct of clinical research," contends Cynthia Ray, who served as Quintiles' director of clinical operations prior to becoming its staffing and development director. Tim Warneke echoes this impression: "For a novel therapy, it's a tremendous thing to see improvements in patients," even if it's only through reading the reports of the trial. "I feel a part of a valuable discovery." Lee Katterman, a writer based in Ann Arbor, Mich., is editor of Research News, a publication of the University of Michigan.

Multiple Opportunities

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