Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.
A clinical research associate (CRA) is a profession defined by Good clinical practice guidelines (ICH GCP). While ICH GCP uses the term “Monitor” instead of CRA, the two terms are considered to be synonymous.
The main function of a clinical research associate is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a Contract Research Organization (CRO). A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRFs) and communicates with clinical research investigators. Clinical research associates also “assure the protection of the rights, safety and well being of human study subjects.
CRA as a Career Path- Since there are so many different types of clinical trials, the work environment can be dynamic with tasks varying from day to day. CRA’s can specialize in a particular subject area, or go for a broad base of knowledge and hop from topic to topic. And growth potential is strong: As personalized medicine becomes more common, clinical trials will increasingly be needed to make sure drugs and devices work properly.