Working in Clinical Research

A clinical research associate (CRA) sets up, monitors and completes clinical trials.

A clinical trial is a scientific study of the effects, risks, efficacy and benefits of a medicinal product. Trials need to be carried out before a product reaches a hospital or the shelves of the local pharmacy. They are undertaken at various stages, or 'phases', and include: trials on healthy humans; trials on patients with a disease; and studies conducted after the launch of a new product to monitor safety and side-effects during large-scale use.

Clinical trials are conducted by pharmaceutical companies or contract research organisations (CROs) on their behalf.

Typical work activities

Typical work activities include:

• developing and writing trial protocols (outlining the purpose and methodology of a trial);
• presenting trial protocols to a steering committee;
• designing data collection forms, known as case record forms (CRFs);
• co-ordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects;
• managing regulatory authority applications and approvals (that oversee the research and marketing of new and existing drugs);
• locating and assessing the suitability of facilities at a study centre;
• briefing doctors/consultants (or investigators) on conducting the trial;
• setting up the study centres, which includes ensuring each centre has the trial materials and training site staff to trial specific and industry standards;
• monitoring the trial throughout its duration, which will involve visiting the study centres on a regular basis;
• verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV);
• collecting completed CRFs from hospitals and general practices;
• writing visit reports;
• filing and collating trial documentation and reports;
• ensuring all unused trial supplies are accounted for;
• closing down study centres on completion of the trial;
• discussing results with a medical statistician, who usually writes technical trial reports;
• archiving study documentation and correspondence;
• preparing final reports and occasionally manuscripts for publication.

The job of a clinical research associate (CRA) can vary tremendously. In some companies, you would be involved in the whole process: sitting down with the doctor who has the idea for a trial; working out a protocol; and writing up reports after the analysis has been done. In others, a medical adviser would initiate the trial - the CRA would become involved in collecting data once the trial had been set up.

Requirements

This area of work is open to graduates with a degree in life and medical sciences. In particular, the following subjects may increase your chances:

• biochemistry;
• anatomy;
• biology;
• biomedical science;
• dentistry;
• microbiology;
• medicine;
• nursing;
• immunology;
• molecular biology;
• toxicology;
• physiology;
• pharmacology;
• pharmacy.

Entry without a degree or with an HND only is unlikely. It is occasionally possible to enter from the administration side, e.g. as a study-site co-ordinator in The National Health Service (NHS) or as a clinical trials administrator.

A pre-entry postgraduate qualification may be useful. In the UK, there are MSc/diploma courses available in clinical research that include clinical trials within them. Some companies rate these highly, but others do not. It is wise to ask prospective employers which category they fall into. A relevant PhD can be advantageous in some companies. It can be considered as highly relevant work experience and may count towards gaining promotion to senior positions or moving into protocol development.

It is relatively unusual for a graduate with no relevant prior experience to go straight into this area of work, although some companies will recruit recent graduates with the necessary personal skills. Graduates without previous experience are more likely to enter the field at a lower level, e.g. as a clinical data co-ordinator or clinical trials administrator, without the involvement of initiating and designing the trials. Experience in this type of work will generally qualify you to move on to a full clinical research associate (CRA) position.

Relevant pre-entry experience can include a background in nursing, pharmacy or medical sales, clinical laboratory work, clinical data work and academic or pharmaceutical research.

Potential candidates will need to show evidence of the following:

• excellent communication skills (both written and oral) and the ability to build effective relationships with trial centre staff and colleagues;
• the ability to motivate others;
• numeracy;
• an eye for detail;
• the ability to multi-task and think on your feet;
• good organisational, IT and administrative skills - the job involves a lot of documentation and recording of information. Traditional paper files are rapidly being replaced by electronic records, which requires the use of various information systems, including the use of web-based data capture (WBDC) and E-clinical.

In addition, you must understand the importance of good clinical practice (GCP), which is now law throughout Europe. A clean driving licence is essential.

The ever-tightening government regulations on the licensing of new drugs and re-licensing of existing drugs means that the need for CRAs is increasing. Competition is strong amongst graduates with no relevant experience; work experience in a clinically relevant field will considerably improve your chances.

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