When you want to grow into a clinical research associate (CRA) role, first ask yourself the question: “Is this career path fit for me?”. Do you have an idea of what clinical research is?
Effective communication and data review skills are good to have for being an excellent CRA. But most successful CRA’s (clinical research associate) share one common trait: Diligence! Diligence leads to quality and that in turns lead to credible data.
What does a CRA job look like?
The Clinical Research Associate has an important responsibility within the clinical trial process. (S)he needs to guard safety, rights, and well-being of (patients). They verify if clinical trial data are accurate verifiable from source documents and complete.
Following the protocol according to good clinical practice (ICH-GCP guidelines) is important.
The CRA goes to the hospitals (clinical site) for monitoring visits to support the site personal (study nurses) and verify clinical research documents. Documents can include Patient Informed Consent Forms (ICFs), clinical study protocol or CRFs (clinical case report forms).
It is really important that the CRA has a thorough understanding of the organization’s standard operating procedures. Most Clinical Research Associates probably need to provide study progress reports.
CRA’s usually reports to the Clinical Trial Manager (large companies) or Medical Director (smaller companies). And more senior CRA’s tend to help their manager (CTM) with clinical site and study feasibility.
Some of the other tasks of a CRA are the preparation of Trial master files (TMF), preparation of Ethical committee document, aid with the investigator meeting, site initiation visits, meet clinical investigators, manage clinical central laboratory relation, monitor patient recruitment, find inconsistencies in the case report forms against the source documents or reporting of (serious) adverse event.
How to start as a CRA?
For past years the best way to start working in clinical research as a CRA is to start from the bottom up. Best guess is you need to begin working as an administrative assistant in a pharmaceutical company or a clinical research organization (CRO). It is unlikely that they will engage you without certain years of experience even with advanced degrees. Although today, out of necessity, several CRO’s start training freshly graduated candidates again.
Being a CRA really is a job where you must be a people person. You need to love the interaction with people and like to achieve goals together with your team.
It will of course help if you understand clinical research or healthcare systems. We also see that candidates with a hospital background can have an advantage over their peers because they already know how to interact with investigators and site staff.
Important to know!
Being a clinical research associate is the proper role for anyone who likes traveling and experiencing various working environments. As a CRA you will probably work from different places.
Another major advantage is the working hour flexibility and some companies also allow you to work from home.
Last but not least, you will feel like being part of something! Together with your team, you work towards a shared goal: get medicines on the market to cure peoples or at least make their lives better.
Last modified: May 7, 2018