How You Can Save Lives as a Clinical Research Associate |
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March 15, 2007
By Kathy A. Johnson
Health Care Programs Columnist
Before a drug can be prescribed to patients, clinical trials must prove that it is safe and effective in humans. Clinical trials, also called clinical research studies, are scientific studies of how a medicine or treatment works in people, and what risks and benefits it has. These studies must be carefully devised, monitored, and documented, and that's where the clinical research associate (CRA) comes in.
Clinical research associates help design and plan clinical trials, as well as monitor their progress to ensure scientific integrity and the safety of study subjects. They must make sure good clinical practices and the study's protocol are maintained.
Other duties include verifying, reviewing, and maintaining subjects' informed consent forms, regulatory reports, and other documents, as well as making sure adverse reactions are documented and reported. Travel is frequently required, as a clinical study may be conducted in many locations at the same time. Clinical research jobs may be found with pharmaceutical companies, contract research organizations, or government agencies.
Many CRAs have a science or health background, but they do not have to be MDs. Many colleges and universities offer specialized clinical research training, and some programs may be completed online. In addition, the Association of Clinical Research Professionals offers clinical research certification.
CRAs must be able to work independently, as well as on a team. Since they work with patients, families, and medical personnel, they should be able to communicate clearly. CRAs should also be able to handle detailed paperwork, because case reports, forms, and regulatory documents must be recorded and kept.
One clinical research organization estimates that approximately 50,000 clinical trials are currently taking place in the U.S. CRAs play a key role in these trials, and in the research and development of drugs and treatments that improve health care for all of us.
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About the Author
Kathy A. Johnson has written articles on health, fitness, and many other topics in her career as a freelance writer and editor. She lives in Florida, and is the features editor of Forum, a bimonthly publication of the national mothers group, Mothers & More.
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