The biotechnology boom is creating more opportunities for clinical research professionals trained to help bring the latest drug therapies from the laboratory to market.
"There are plenty of job opportunities in the clinical research field today and for the foreseeable future," says Carol McCullough, RN, MBA, director of credentialing, certification and accreditation for the Association of Clinical Research Professionals (ACRP). "The demand continues to grow as the drug pipelines swell."
Aside from the physicians who investigate the effects of drug therapies on patient populations, trials require clinical research coordinators (CRCs) and clinical research associates (CRAs) to ensure testing is conducted according to strict FDA guidelines.
Coordinating the Site
CRCs, also called research nurses, site managers or site auditors, work at the clinical site -- typically a hospital -- under the immediate direction of the investigator. CRCs prepare the site; recruit, screen and enroll patients; ensure the quality of case report forms; maintain source documents and ensure overall site quality.
Most employers prefer at least two years of acute-care nursing experience or some other type of healthcare experience. Full-time CRCs can expect to earn about $50,000 a year, according to the ACRP's 2003 compensation and benefits survey. With the proper education plus their on-the-job experience, CRCs can move up to CRA roles.
Overseeing the Trial
CRAs, who are required to hold an RN or bachelor's degree in nursing or a life science, such as biology or biochemistry, ensure that research site personnel conduct the study according to Good Clinical Practices. CRAs make sure the site meets all applicable regulatory requirements. They also track adverse events, review the accuracy of drug accountability records and perform other administrative duties.
"The CRA is the watchdog for the sponsor of the clinical trial," McCullough says. "CRAs are usually employed full-time or on a contract basis by the sponsor, which may be a pharmaceutical company or a Contract Research Organization." Biotechnology firms, medical device manufacturers and academic institutions that run compliance programs may also hire CRAs.
Full-time CRAs travel from site to site and can expect to earn about $70,000 a year, according to the ACRP survey. The next step up for a CRA is often a project management role that pays more and offers more responsibility for overseeing trials.
Education and Training
"Because of all the regulations, you can't just throw people into the fire and hope they do well," says Jill Matzat, RN, BSN, CRA, former chairperson of the ACRP's Trainers Forum and founder of Medical Research Management, a CRA training company. "If you violate the regulations, then you violate laws. Training is essential to success in this field."
A number of colleges and universities now offer degree programs or certificates in clinical research. Among them are Boston University, Duke University, Durham Technical Community College and George Washington University.
Continuing-education credits for healthcare professionals interested in moving into clinical research are available through the ACRP, CenterWatch, a publishing and information services company, and the Society of Clinical Research Associates (SoCRA), among others.
In addition, professional organizations offer certifications that can enhance a clinical research professional's credentials.
Breaking into the Field
If you're pursuing a healthcare degree now, paying your dues as an administrative or project assistant or performing data-entry functions at a research site will allow you to familiarize yourself with the requirements and regulations that govern clinical trials. With that knowledge, you'll stand a better chance of obtaining a CRA position once you graduate.
If you are a working healthcare professional who would like to shift into a clinical research role, experts say joining a professional organization could provide you with networking opportunities that can lead to a well-paying position in the field.
"Your best bet is to network and bring your skills and abilities to the forefront," says Carol Connell, RN, former SoCRA president and director and development operations team leader for Pfizer. "Many professional organizations have local chapters that put you in contact with clinical research leaders in your community."