There are roughly two halves to the industry: the pharmaceutical companies, who develop medical products, and the clinical research organisations (CROs) who provide a range of services including resources and expertise to pharmaceutical companies. If you are just starting out, it is easier to enter the industry through a CRO.
What do they do?
Most people associate CRAs with study monitoring, but their activities can extend far beyond verifying and checking data at the investigator’s site (hospital or GP Surgery). A list of possible duties include:
- Providing input to a study plan
- Input into the protocol of a study (ie, the document that describes the design, methodology and organisation of a trial)
- Reviewing and providing input for essential study documents
- Selecting investigators
- Assisting investigators in obtaining approval from ethics committees
- Ensuring that the investigator and other site staff, such as study nurses and pharmacists, understand all their responsibilities and, if necessary, will arrange training for them
- Making sure that patients know what a trial involves and have given their consent.
Can I do it?
A science degree is not a necessity, but relevant GCSEs and A-levels are a must. Clinical research posts are of particular interest to fresh graduates, nurses, pharmacists, laboratory staff and those working in allied fields both in the pharmaceutical industry and NHS. Good communication is key, because you may be working with hospital specialists such as surgeons, cardiologists and oncologists. You will also be dealing with GPs, nurses, scientists, pharmacists and administrative staff. How you interact with these personnel is as important as attention to detail. A good CRA needs to be confident and professional – you will need to be able to influence and negotiate. As technology advances, CRAs are becoming involved in electronic data capture. CRAs may have to provide training and support to investigators who are not familiar with these newer systems.
Career development
It is useful to do an MSc in Clinical Research, if possible. Alternatively you could attend one of the short courses run by the Institute of Clinical Research. Once you have entered the world of CRAs the sky is the limit – many go on to high-level management, while others move into sales, marketing or wherever they feel they can meet a better challenge. Most tend to stay in their job, though, as it is valued, well paid and challenging.
See www.abpi.org.uk and www.instituteofclinicalresearch.org for further information.
