Clinical Research Associate
Clinical research associates (CRAs) organise and run trials to test the safety of new medicines and to see if they work well. They choose and set up sites where tests take place, supervise trials and monitor the quality of data from the trials.
Also known as
- Pharmaceutical Trials Scientist
- Scientist, Clinical Trials
- Clinical Trials Scientist
- Clinical Research Officer
Video: - Rebecca: Veterinary Clinical Research Associate
Clinical trials test the safety and efficiency of new medicines. These trials can take several years to complete, and it can be years before the results are clear. The tests are to find out things like the benefits, risks and side-effects of the medicine.
As a Clinical Research Associate, you may be involved in all stages of clinical research, and in all the stages of a trial. Clinical trials usually take place in hospitals or clinics. You may normally travel between several testing sites.
You will usually work as part of a team, alongside Scientists with other specialist knowledge. The team can also include Statisticians, IT Specialists and Health Economists.
As part of the team, you are responsible for choosing and setting up sites for the trial, monitoring the quality of data and supervising trials.
You will have to test the accuracy of the data entered at the site. You must also protect the rights and safety of the people involved.
Organising a trial can involve:
- putting together trial information to give to ethics committees, for example, to ensure that patients won't be put at unnecessary risk
- pre-trial procedures, for example, collecting all the necessary documents and visiting the site of the investigation to make sure it is suitable
- training site staff
- being responsible for, and keeping to, a budget
Before the trial starts, you might have to write detailed plans, called 'protocols', that set out exactly how the drug will be tested and details such as the ages of the people involved in the trial.
Clinical trials involve several phases.
Phase 1: usually involves 20-80 healthy volunteers or closely-monitored patients, over a few days to a few weeks. This phase helps the trial's sponsor (for example, a pharmaceutical company) find out what effect the drug has on the body.
You will record details about any side-effects and provide information that helps others work out what dose will be used in the next stage of testing.
Phase 2: usually involves between 100 and 300 patients who have the disease that's being studied. These give information on how effective the medicine is in treating the symptoms of the disease. You will check more information about the medicine's safety.
In some trials, the new medicine is compared with the best treatment that is already available; in others, the comparison is with a placebo. The patient doesn't know whether they are taking the new medicine or not.
Sometimes, a patient's health improves because they strongly believe in their treatment and so expect to get better ('the placebo effect'). Using a placebo helps the sponsor know what the actual effects of a drug are compared to the placebo effect.
Phase 3: is on a much larger scale (usually involving thousands of patients) and can take several years to complete. Again, some patients receive the medicine; others take an existing treatment or a placebo.
Phase 4: takes place after the medicine has become available to the public. The goal is to study how safe and effective the medicine is over time.
Before, during and after a trial, you will visit the sites involved in the investigation. During the trial, you will visit every four to six weeks, for example, to oversee the recruitment of patients and to make sure the trial is taking place according to the instructions in the protocol. This means that your work can involve lots of travel, possibly to other countries.
Throughout the process, you might have to make sure that the patients' experiences have been accurately recorded and reported.
The analysis and final reports will be included in data sent to regulatory bodies, to seek approval to market the new medicine.
Being able to read, write and speak Welsh may be an advantage when you’re looking for work in Wales.
Personal Qualities and Skills
To become a Clinical Research Associate, you will need:
- a high level of scientific knowledge and an interest in fighting disease
- a logical, methodical approach to your work
- organisational and planning skills to manage trials
- patience - it can take many years to test a drug fully
- teamwork skills to work with other Scientists, Doctors and other healthcare professionals
- the ability to work well on your own
- willingness to travel to investigation sites
- number skills
- communication skills
- confidence, leadership and time-management skills
Pay and Opportunities
The rates given below are approximate.
- Starting: £27,500 - £30,000
- With experience: £35,000 - £41,000
- Senior Clinical Research Associates earn £44,500 - £50,000
Hours of work
Most work around 37 hours, Monday to Friday. However, late finishes and some weekend work might be required. You might have to travel to trial sites, making working days longer.
Where could I work?
Employers are contract research organisations, pharmaceutical companies, health research institutions, hospitals and universities.
Contract research organisations sometimes employ you on a freelance or part-time basis. There is a trend towards working from home and travelling to trial centres.
Opportunities for Clinical Research Associates occur in towns and cities throughout the UK.
Where are vacancies advertised?
Vacancies are advertised on major employers' websites, specialist job boards, for example, for the pharmaceutical industry, the NHS Jobs website, professional journals and national newspapers.
'Clinical Research Focus' (the members' journal of The Institute of Clinical Research) includes vacancies.
Entry Routes and Training
To become a Clinical Research Associate, you will need a degree in a relevant subject, such as:
- biomedical science
It can be an advantage to have a relevant postgraduate qualification because competition for entry is very strong.
A great way to get into this career is through an internship. Take a look at our information article '
Pharmaceutical companies and contract research organisations give on-the-job training. They might also enable you to go on external training courses, including one- and two-day courses offered by the Institute of Clinical Research. Some companies enable graduates to work towards postgraduate qualifications during their training.
Clinical Research Associates usually handle one set of trials. Progression is into a Clinical Research Executive position that involves managing several studies. After this, you could become a Senior Clinical Research Scientist, with broader product management responsibilities.
Previous experience within a science, mathematical or research based environment will help you get into this career.
Rehabilitation of Offenders Act
This career can be an exception to the Rehabilitation of Offenders Act 1974, for example, where posts involve contact with patients.
This means that you must supply information to an employer about any spent or unspent convictions, cautions, reprimands or warnings, if they ask you to. This is different from other careers, where you only have to reveal information on unspent convictions if you are asked to.
Entrants to this career have degrees in a wide variety of subjects, including biology, biochemistry, biomedical science, chemistry, medicine, nursing, toxicology and pharmacology.
Entry requirements for degree courses vary depending on the subject, so you should check college/university websites very carefully.
Generally, you will need:
- 2/3 A levels, including at least one science subject
- GCSEs at grade C/4 and above in your A level subjects
- a further 2/3 GCSEs at grade C/4 and above, including English and maths
Equivalent qualifications, such as BTEC level 3 and the International Baccalaureate Diploma, might be acceptable for entry.
Some universities accept the Welsh Baccalaureate as equivalent to 1 A level.
It is illegal for any organisation to set age limits for entry to employment, education or training, unless they can show there is a real need to have these limits.
If you don't have the qualifications you need to enter a relevant degree, you might be able to start one after completing a college or university Access course, such as Access to Science. You don't usually need any qualifications to start an Access course, although you should check this with the course provider.
Some employers sponsor adults on MSc postgraduate courses.
- 12% of people in occupations such as clinical research associate work part-time.
- 28% have flexible hours.
- 4% of employees work on a temporary basis.
Professional institutionsProfessional institutions have the following roles:
- To support their members.
- To protect the public by keeping standards high in their professions.
The Institute of Clinical Research is the professional institution for this career.
Apprenticeships: Get In. Go Far
National Apprenticeship Service (NAS)
Tel: 0800 015 0400
NHS Wales Careers
Publisher: National Leadership and Innovation Agency for Healthcare
Step into the NHS
Tel: 0345 6060655
Skills for Health
Skills for the health sector
Address: Goldsmiths House, Broad Plain, Bristol BS2 0JP
Tel: 0117 9221155
Association of the British Pharmaceutical Industry (ABPI)
Address: 7th floor, Southside, 105 Victoria Street, London SW1E 6QT
Tel: 0870 8904333
Association of the British Pharmaceutical Industry (ABPI) Scotland
Address: Crichton House, 4 Crichton's Close, Edinburgh EH8 8DT
Tel: 0131 5230493
Address: Unit 5, Mandarin Court, Centre Park, Warrington, Cheshire WA1 1GG
Tel: 01925 515200
Institute of Clinical Research (ICR)
Address: 10 Cedar Court, Grove Park, White Waltham Road, Maidenhead
Tel: 01628 501700
Careers Wales - Welsh Apprenticeships
Tel: 0800 028 4844