CLINICAL RESEARCH
A CRA spends a lot of time visiting clinicians who are performing clinical trials to ensure that everything is being done correctly, that the patients are not being compromised, and that the data collected are accurate. A CRA can work either for a pharmaceutical, biotechnology, medical device companies, academic medical centers, government agencies or a Contract Research Organization (CRO). The latter is contracted by companies to run their clinical trials.
A clinical trial is a research study in humans of a drug, medical device, biologic (such as a vaccine) or treatment. Individuals who volunteer to participate in a clinical trial are called “subjects” or “participants”. We generally conduct clinical trials on these products to determine if they are safe and effective for use by the general population. For example, pharmaceutical products must be tested in clinical trials before they are approved to be prescribed by a doctor.
Skills needed to perform this job are problem solving, interpersonal skills, and the ability to work as part of a team while being independent. The most important skill is clinical skills. That’s why nurses are ideal candidates for CRA positions and why many apply for positions and get them without any formal training or education as a CRA. However, it is recommended that you do increase your chances of getting a job as a CRA by taking a few courses offered by the following associations, your local community/technical college or any other entity offering classes.
Training for CRA is offered worldwide. If you can’t find something close to home, contact any of the associations here and they will guide you in the right direction.
The Best Resource
CenterWatch Clinical Trials Listing Service. This site has everything: Reading, training, jobs, associations, online training programs. www.centerwatch.com/index.html
Associations
Association of Clinical Research Professionals www.acrpnet.org
The Society of Clinical Research Associates, Inc www.socra.org
The Institute of Clinical Research www.instituteofclinicalresearch.org
Reading
From Test Tube to Patient: Improving Health Through Human Drugs. Published by the US Food and Drug Administration Center for Drug Evaluation and Research. (1999). http://www.fda.gov/fdac/special/newdrug/ndd_toc.html
So You Want to Be a CRA: A guide to careers in clinical Research (5th ed). Published by Ingenix Pharmaceutical Services (1999).
Stonier, PD (ed), Discovering New Medicines- Careers in Pharmaceutical Research and Development. John Wiley and Sons (1994).
Zivin, JA. Understanding Clinical Trials. Scientific American, April 2000 (p 69-75)
Spilker B. (1997) Guide to Clinical Trials. Philadelphia: Lippincott-Raven Publishers.
Centerwatch http://www.centerwatch.com/patient/backgrnd.html (go here for more information about clinical trials including an online glossary of terms)
Lui, M. and Davis, K. Lessons from a Horse Named Jim (2001) Duke Clinical Research Institute.
Education (These are just a few of the many programs offered throughout the US)
Certificate Program in Clinical Trials University of Washington, Seattle www.outreach.washington.edu/ext/certificates/cli/cli_gen.asp
Certified Clinical Research Associate McMaster University Continuing Education Department Hamilton, Ontario www.mcmaster.ca/conted/ccra/
UNC Chapel Hill School of Nursing Continuing Education Department Clinical Research Associate/Clinical Research Coordinator Course Chapel Hill, NC http://nursing.ce.unc.edu/schedule.html
Clinical Trials Research Associate Program Durham Technical Community College Durham, NC www.durhamtech.edu/html/prospective/programsofstudy/clintrialsqa.htm
Delaware Valley College Certificate Program Delaware, MA www.delval.edu/continuing/certs_cra.htm
The Norton Training Institute for Clinical Research Excellence Lexington, SC www.nortonaudits.com
Rutgers College of Nursing Clinical Research Associate/Clinical Research Coordinator Course Newark, NJ http://nursing.rutgers.edu/
Northwestern Center for Clinical Research Chicago, IL www.medschool.northwestern.edu/nccr/index.html
Who’s Hiring (this list is the tip of the iceburg)
Any, every and all academic medical centers have research and/or clinical trial departments
Quintiles www.quintiles.com
Sarah Cannon Research Institute www.sarahcannonresearch.com
Johnson & Johnson www.jnj.com
Abbott Laboratories www.abbott.com
Clinforce (staffing agency) www.clinforce.com/clinforce/
Prometrika (contact research organization) www.prometrika.com
Actavis www.actavis.com
Covance www.covancecareers.com
Delta-Pharma (staffing agency) www.delta-pharma.com
