Clinical Research Is Not a Unique Business But Is a Bit Different.
Clinical trials are conducted with strict regulations. Companies which conduct clinical trials must follow ICH-GCP.
It is really hard to find a clinical research associate entry level jobs. Most of the companies won’t hire people without any previous “monitoring experience”. But, some people actually get managed to get hired immediately as a CRA.This blog is a gist of expert opinions by experienced people in the sector telling how to become clinical research associate and pursue a career in the clinical sector.
Why is it essential to have prior experience to become a CRA?
All companies in clinical research, pharma companies as well as CROs, must keep CVs of all their employees. Sponsors could request to review the CV of any CRA who will monitor their study.
According to ICH-GCP section 5.18.2 “Selection and Qualifications of Monitors”:
(a) The sponsor should appoint monitors.
(b) They must have experience and also have the scientific and clinical knowledge necessary for monitoring the trial adequately. A monitor’s qualifications must be well documented.
(c) Monitors must be quite familiar with the investigational product(s), the protocol, written informed consent form and every written information which are to be given to subjects, the sponsor’s SOPs, GCP, and any regulatory requirement(s).
Sponsors, or their representatives, will do the “audits” of companies with whom they work in collaboration.
During an audit they would check:
The company’ standard operating procedures
How storage and data filing is done
CV of the staff and they would especially see documented skills to work with clinical research.
1. How to get an experience (the long way)
The best way is to work as either:
Clinical research coordinator (CRC)
Clinical trial assistant (CTA)
It might also be a good idea to volunteer for any duties on clinical trials. This you could consider during any spare time while yet studying. But if you’re already graduated volunteering is not recommended.
2. The shortcuts
Apply for small or big companies.
You can work as a CRA for two types of companies:
Clinical research organization (CRO)
Most often people who look for CRA jobs start by contacting the big companies by sending their CV and cover letter to the big pharma companies or the well known CROs.
But what about the smaller ones?
If you do online searches, you will find several small to mid-sized CRO’s. Most people do not apply to these companies.
A smaller company don’t have their own recruiters. Their budget is quite limited, and sometimes they don’t even announce open positions.
What is best for a future career – a small or a big company?
It depends on your goals. In the long run, it’s best to earn an experience from both.
In your early career, a smaller company has some advantages.
-You will get quick responsibilities.
-Your tasks will be versatile.
Promotions are often difficult.
How Essential Is Getting a CRA certificate
To mention, you can get a “real” CRA certificate only if you have been working as a CRA.
There are several scam companies who offer training courses to get people without monitoring experience “certified”. Be aware of them.
With this, we conclude. Stay connected with this space for more discussions on Clinical Research and Clinical Trials.
And get yourself enrolled with one of the best training institutes in Pune.
Study GCP and do relevant courses instead.
If you don’t have any experience in monitoring, you can enhance your chances to get an entry-level CRA position if you do some courses.
Won’t there always be someone with prior experiences seeking the same job or position?
Yes, there would be. If you apply for vacancies at big companies only, you can face this problem. Hence, you should also aim for the smaller ones.
Don’t only apply for positions in advertisements.
Finding new employers is quite time-consuming and quite expensive task.
Usually, smaller companies prefer to hire by “word to mouth” or pick their candidates from “spontaneous” applications to save money and time.
You need to send your CV and a Cover Letter to several companies that aren’t recruiting actively at the moment.
You can more easily find clinical research associate jobs at entry level in the smaller companies. Besides relevant education, some GCP training or a specific course in clinical research is necessary. While looking for CRA positions in big companies, you need to apply in smaller companies as well to gain experience.