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:

Clinical trials scientist
Pharmaceutical trials scientist

Work activities

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. Clinical research associates (CRAs) 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. CRAs normally travel between several testing sites. The CRA 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, the CRA is responsible for choosing and setting up sites for the trial, monitoring the quality of data and supervising trials. They have to test the accuracy of the data entered at the site. They 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, more senior CRAs (project managers) 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 I 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. CRAs 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 II 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. CRAs 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 III 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 IV 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, CRAs visit the sites involved in the investigation. During the trial, they 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 the work of a CRA can involve lots of travel, possibly to other countries. Throughout the process, CRAs 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.

Personal qualities and skills

To be a clinical research associate you’ll 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. You will also need 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

Pay rates for clinical research associates (CRAs) vary. According to job site Glassdoor, CRAs earn between £31,000 and £43,000 on average (January 2024, based on 330 salaries), although you will start on a lower salary while you are in training. Higher salaries are possible, depending on employer and responsibilities.

Most work a full-time week, Monday to Friday. However, late finishes and some weekend work might be required. CRAs might have to travel to trial sites, making working days longer.

Employers are contract research organisations, pharmaceutical companies, health research institutions, hospitals and universities. Contract research organisations sometimes employ CRAs on a freelance or part-time basis. There is a trend towards working from home and travelling to trial centres. Opportunities for CRAs 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. The members’ journal of The Institute of Clinical Research includes vacancies.

Entry routes and training

To become a clinical research associate (CRA), you will need a degree in a relevant subject, such as:

Biochemistry
Biology
Biomedical science
Chemistry
Immunology
Medicine
Nursing
Pharmacology
Pharmacy
Statistics
Toxicology.

It can be an advantage to have a relevant postgraduate qualification because competition for entry is very strong.

Pharmaceutical companies and contract research organisations give on-the-job training. They might also enable CRAs 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.

CRAs 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 responsibilities.

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.

Qualifications

Entrants to this career have degrees in a wide variety of subjects, including biology, biochemistry, biomedical science, chemistry, medicine, nursing, toxicology, pharmacy and pharmacology. Entry requirements for degree courses vary depending on the subject, so you should check prospectuses carefully.

Generally, you will need:

Two to three A-levels, including at least one science subject.
GCSEs at grades 9-4 in your A-level subjects.
A further 2/3 GCSEs at grades 9-4, including English and maths.

Equivalent qualifications, such as Edexcel (BTEC) level 3 Nationals and the International Baccalaureate Diploma, may be acceptable for entry.

Adult opportunities

Age limits: 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.

Related careers

Pharmacologist
Scientist
Toxicologist