Clinical research associate
A clinical research associate (CRA) sets up, monitors and completes clinical trials.
The clinical trials are scientific studies of the effects, risks, efficacy and benefits of new and existing medicines. 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 activities include:
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 and the CRA would become involved in collecting data once the trial had been set up.
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:
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 coordinator 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, which provide experience in clinical trials. A relevant PhD can also 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 coordinator or clinical trials administrator, without the involvement of initiating and designing the trials. Once experience has been gained in this type of work, it is generally possible 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.
Candidates need to show evidence of the following:
In addition, you must understand the importance of good clinical practice (GCP), which is now law throughout Europe. A clean driving licence is usually essential.
The ever-tightening government regulations on the licensing of new drugs and re-licensing of existing drugs mean that the need for CRAs is increasing. Competition is strong amongst graduates with no relevant experience and therefore work experience in a clinically relevant field will considerably improve your chances.
For more information, see work experience and internships and search courses and research.
Training for clinical research associates (CRAs) takes place mainly in-house and on the job. Where required, external courses can be accessed. Training will include: clinical research and data management; good clinical practice; standard operating procedures; ethical and quality issues; personal development; and IT skills.
A breadth of experience can be gained by working in various therapeutic areas and phases of clinical research.
Some companies offer block or day release to pursue related courses. Formal academic qualifications include postgraduate diplomas and certificates, as well as Masters in subjects such as clinical research, clinical pharmacy, pharmaceutical medicine or clinical pharmacology. These courses can facilitate professional development and career advancement.
There are training schemes to help new graduates become CRAs. These schemes combine classroom training and practical learning through job placements. The length of the scheme may vary from 3 to 12 months with a potential job offer at the end.
The Institute of Clinical Research (ICR) offers a continuing professional development (CPD) scheme for its members. This will complement company training schemes.
Career structures vary from company to company. How quickly a CRA can move up the grades depends on a range of factors including motivation, ability and previous experience.
You may begin as a CRA, handling a single study, setting up and organising clinical trials, liaising with centre staff and undertaking the majority of the necessary administration. From here you could move to a clinical research executive role, where you would be responsible for numerous studies and have more involvement in activities such as protocol development, coordination of ethics committees and design of case record forms (CRFs). This role could lead on to that of a senior clinical research scientist where you would manage projects, possibly even on an international scale and mentor and train junior staff.
CRAs within a contract research organisation can build up and widen their experience with a variety of sponsor pharmaceutical companies in different therapeutic areas and in different phases of clinical research. This could lead to a move to work for a pharmaceutical company.
Self-employment may also be possible, as CRAs are employed on a freelance basis by certain companies. This should usually only be considered when contracts and clients have been developed. Some companies prefer PhD holders for senior posts. For positions such as medical adviser or medical director, a medical degree is usually required.
Typical employers include pharmaceutical companies or contract research organisations (CROs), which conduct research on behalf of pharmaceutical companies.
A CRO may organise the placement of a clinical research associate (CRA) on contract with the sponsor (the pharmaceutical company). Reporting directly to the sponsor, the CRO may organise and conduct the whole study or any part of it, with the CRA reporting to the organisation and feeding back to the sponsor. Alternatively, the CRO may organise and conduct the entire clinical trial programme.
Large contract organisations are more likely to recruit an inexperienced graduate into a monitoring role and provide the training to progress to the level of a CRA.
Hospital academic departments occasionally employ CRAs in clinical trials units.
Useful websites include:
There are a number of specialist recruitment agencies dealing with clinical research and recruiting candidates for permanent positions and contract work. Contract research organisations and pharmaceutical companies may also advertise vacancies on their own websites.
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