A clinical research associate (CRA) runs clinical trials to test drugs for their effectiveness, risks and benefits to ensure they are safe to allow on to the market. They may work on new as well as existing drugs and are usually employed by either a pharmaceutical company or a contract research organisation (CRO) which works on behalf of pharmaceutical companies.
The CRA will typically be involved in all stages of the clinical trial, including identifying an investigational site and setting up, initiating, monitoring and closing down the trial.
Clinical trials may be carried out 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 drug to monitor safety and side effects.
Tasks carried out by a CRA vary depending on the employer but will typically 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 report forms (CRFs);
- coordinating 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;
- identifying and assessing the suitability of facilities to be used as the clinical trial site;
- identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site;
- liaising with doctors/consultants or investigators on conducting the trial;
- setting up the trial sites, which includes ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product. Plus training the site staff to trial-specific industry standards;
- monitoring the trial throughout its duration, which involves visiting the trial sites 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 and filing and collating trial documentation and reports;
- ensuring all unused trial supplies are accounted for;
- closing down trial sites 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.
- Starting salaries for clinical research associates (CRAs) are in the region of £22,000 to £28,000. Some graduate positions may offer salaries of around £30,000. It is likely these posts will require some experience in a related area.
- With experience and working as a senior CRA/CRA II you can earn a salary of £33,000 to £40,000. In some roles, salaries of up to £60,000 can be reached.
Salaries vary from company to company. Additional benefits, such as a car allowance and bonus are typically offered.
Income figures are intended as a guide only.
Working conditions vary between companies, although the hours are usually Monday to Friday. Extra hours are worked regularly in the evenings, although weekend or shift work is uncommon.
Part-time work is possible, as are career breaks. Short term contracts of 6 to 12 months with a company are common, meaning you may work more like a contractor than permanent employee.
What to expect
- If you are field-based you will mainly be on the road, dealing with doctors and research nurses in trial centres, GP practices or hospitals. Some companies have in-house, office-based CRA roles with virtually no site visit responsibilities; the focus in this role is on document review and management.
- Self-employment or freelance work is possible with experience (usually four years or more).
- Most UK pharmaceutical companies are located in the south of England. Field-based positions are generally found in key locations throughout the UK. Some jobs, for example in a company laboratory, can be found locally while others are regionally based.
- Time deadlines can make the work stressful and work may be done in teams or individually.
- The job can involve a lot of travelling, especially if working in a field-based role. You may be out of the office three or four days a week, possibly including overnight stays. Some companies operate a system whereby the CRA specialises in a specific disease area and covers the whole of the UK. Others operate their CRAs on a regional basis.
- Working for an international company may involve coordinating trials abroad, in which case a considerable amount of overseas travel would be necessary.
To become a clinical research associate (CRA) you need to have either a degree or postgraduate qualification in nursing, life sciences or medical sciences.
This could include subjects such as:
- biomedical science;
- molecular biology;
- pharmacology or pharmacy;
Entry without a degree or with an HND only is unlikely. It is occasionally possible to enter from the administration side, for example, you could start as a study-site coordinator in the NHS or as a clinical trials administrator. However, you would need substantial experience and possibly further qualifications to progress.
It is possible to take a postgraduate course in clinical research and this could give you valuable experience in clinical trials and an advantage against competition when applying for jobs. 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.
You will need to show:
- 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 and 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 through computerised processes such as clinical trial management systems and electronic data capture.
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 for travel between trial sites and your office.
If you have no relevant prior experience it is likely that you'll enter this area of work at a lower level, such as a clinical data coordinator or clinical trials administrator, where you will not be involved in initiating or designing the trials. Once you have gained experience, you will then move on to a full CRA position. A small amount of companies may recruit graduates without experience if they have the necessary personal skills, but it is a good idea to get some pre-entry experience if possible.
This can include any work that uses scientific and analytical skills. It can be work in areas such as:
- medical sales;
- clinical laboratory work;
- clinical data work;
- academic or pharmaceutical research.
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.
Typical employers include pharmaceutical companies or contract research organisations (CROs), which conduct research on behalf of pharmaceutical companies.
A CRO will organise the placement of a clinical research associate (CRA) on behalf of the sponsor (the pharmaceutical company) and may be involved in planning, organising and conducting the whole study or just part of it. The CRA will report back to the organisation and will feed back to the sponsor.
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.
Look for job vacancies at:
Contract research organisations and pharmaceutical companies may advertise vacancies on their own websites.
Training for clinical research associates (CRAs) takes place mainly in-house and on the job. It can vary from company to company with some employers providing a structured system of training.
You may be placed on an external training course, for example the Institute of Clinical Research (ICR) offers various courses in the areas of:
- risk-based monitoring;
- the principles of good clinical practice (GCP);
- effective clinical trial project management;
- skills and competencies of a clinical trials manager.
You can also choose to take an ICR exam which awards a certificate and diploma and provides evidence of your knowledge and experience as a clinical research professional. Find out more at Institute of Clinical Research: Learning.
The ICR has a continuing professional development (CPD) scheme for its members and many of the courses it runs offer CPD points.
A breadth of experience can also be gained by working in various therapeutic areas and phases of clinical research.
Some companies offer block or day release so their employees can 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;
- clinical pharmacology.
These courses can facilitate professional development and career advancement.
Career structures vary from company to company. How quickly you can move up the grades depends on a range of factors including motivation, ability and previous experience.
Before becoming a clinical research associate (CRA), you may begin at a lower level such as a clinical trial administrator or junior CRA.
Once you have progressed to the CRA role there are several different levels you can work at which include:
- CRA level I - working on pre-trial procedures, setting up and organising clinical trial sites (with some supervision), archiving documents and correspondence.
- CRA level II - selecting investigators, coordinating ethics committee and regulatory authority applications, supervising trial supplies and attending investigator meetings.
- CRA level III/Senior CRA - any of the above tasks plus supervising, training and mentoring junior staff, project management of whole trials possibly on an international scale, protocol development and design of case report forms (CRFs).
If you work within a contract research organisation you can build up and widen your experience with a variety of sponsor pharmaceutical companies in different therapeutic areas and in different phases of clinical research. This could allow you to move to a pharmaceutical company.
Self-employment may be possible, as CRAs are often employed on a freelance basis by certain companies. This should usually only be considered when you have developed experience, contacts and clients.