According to Good Clinical Practice (GCP) a clinical research associate (CRA) is a clinical research professional that “monitors” trials. Thus they are also referred to as “monitors”. An experienced CRA can be promoted for a position as a “senior CRA” also known as “CRA II”. These two additional terms are widely used and accepted by the industry but they are not clearly defined by ICH-GCP. Most CRA’s will sooner or later reach this level.
I certainly know this can be confusing, especially if you’re new to clinical research or still are looking for your first job.
Sometimes you will see this title in job ads. Some may mistakenly assume that it would be easier to get an entry-level job as “CRA” than “CRA I”. Others may assume it’s the other way around. However, in general there’s no difference between the titles.
Companies that use the terms CRA II (and CRA III) in their organization, usually prefer a consistent terminology, and therefore also use “CRA I”.
Most big companies require at least 2 years of experience as a CRC or CTA, or equivalent. However, smaller companies sometimes hire a certain person anyway. In general it’s also easier to find an entry-level position outside the US if you only have limited experience. In europe I know several people who started imediately as a CRA after graduation. They had been taking some relevant courses in clinical research though.
For more info also see the post: “clinical research associate job description”.
CRA II (Senior CRA or sCRA)
Both these terms are synonymous. According to most job ads you’ll need anywhere between 3-5 years of CRA experience for these positions. There’re no specific rules or guidelines. In general it’s easier to become a senior CRA within the same company if you play your cards rght. Be sure to take all courses you can and ask your employer what it would take to get promoted. Let them know early on that you are interested to develop your skills. In reality, what you need is broad experience which is somewhat achieved by working for several years, but it’s also very important to develop throughoutyour career.
Some companies recruit certain experienced CRA’s for an even higher level. This position can only be found in big companies and organizations. To make it even more confusing sometimes you will see CRA III/senior CRA.
It’s quite difficult to see a common trend here. But usually this would entail a person that is highly skilled within e.g. a certain field. These jobs can e.g. require at least 5 years experience within oncology or pediatrics.
The term can also be used for a job that requires you to work very independently, e.g. as “home-based”. However, the work tasks for a home-based CRA can vary a lot between projects and are not always that complicated.
As explained above, this is the same as CRA II or, sometimes, CRA III.
Which terminology to use?
Personally, I prefer to call it just CRA and Senior CRA.
“Why not use the levels I-III?”
-Beacuse I like consistent terminology. In clinical research you would e.g. never see the term “PM I orPM II” (project manager). You would always say “PM” or “Senior PM”. It sounds much better to use refer to an experienced colleague as “senior” instead of a number. However, as long as you and your correspondants are very clear what you mean, you can use what you prefer.