Clinical trials have to be conducted in line with international, local and federal standards. Monitoring is all about making sure Good Clinical Practice is followed. Thus, the Clinical Research Associate has to be very familiar with GCP. Getting certified as a CRA isn’t necessary but can be very beneficial under some circumstances.
Who should get certified?
Getting certified is especially valuable for CRA’s that have a few years of experience. In that way you will stand out from the crowd when it comes to getting promoted. It’s also very good the day you should discuss a raise. No one can argue that you are well qualified if you passed the certification test. Sponsors prefer to work with experienced or certified CRA’s. For som projects it’s even crucial.
Where to start
At first it’s a good idea to join a professional clinical research organization or network.
They often provide excellent seminars that will increase your knowledge and prepare you for the written exam. You can also network with other clinical research professionals which is very valuable in the future. Here’s a couple of popular organizations:
- ACRP – Association of Clinical Research Professional
- SoCRA – Society of Clinical Research Associates
Also be sure to get the best in-house training possible. If you dont already have a mentor its time to hook up with one.
There are a large number of CRA training courses available online. They are usually a good alternative if you don’t have time to attend classes or if you wan’t a cheaper solution. The drawbacks are that you don’t have the same possibility to ask questions and interact with the other course delegates. the best alternative is to find a certification center that offers both on-site training, lectures and seminars, as well as access to online resources.
Be careful though! There are lots of scam courses offered online, or courses of just really low quality.
If you’re very new to the field of clinical research I highly recommend you to to start with our tutorial on clinical trials, which is completely free of charge!
CRA certification requirements before you can take the exam
This varies between country and organization, but in general prepare that you will need:
- Several years experience as a Clinical Research Associate (usually between 1-3 years)
- Documented relevant training
- Documented experience of relevant CRA tasks
- Letters of recommendations from employer or client
The tests are generally available at various locations several times throughout the year. Be sure to register well in advance since the review process may take several weeks before you are accepted.
The examination application fee is usually between 150-200$. Ask your employer if they are willing to pay the fee for you. After all, its in the interest of the company to keep you up to date.
- Request the core curriculum and ask for practice tests if any.
- GCP – focus especially on everything that is related to patient safety and ethics.
Learn the history behind each of the following and why they are so important to follow during a clinical trial:
- The Nuremberg Code
- The Declaration of Helsinki
- The Belmont Report