Clinical research associate

Clinical drug research is a competitive field and work experience in a scientific or healthcare environment is crucial to become a clinical research associate

As a clinical research associate (CRA), you'll run clinical trials to test new and existing drugs for their effectiveness, risks and benefits to ensure that they are safe for the intended use.

You'll 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.

Responsibilities

Tasks vary depending on your employer and level of experience. However, you'll typically need to:

• develop and write trial protocols (outlining purpose and methodology)
• present trial protocols to a steering committee
• design data collection forms, known as case report forms (CRFs)
• coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects
• manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
• identify and assess the suitability of facilities to use as the clinical trial site
• identify/select an investigator who will be responsible for conducting the trial at the trial site
• liaise with doctors, consultants or investigators on conducting the trial
• set up the trial sites - ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product (IMP)
• train the site staff to trial-specific industry standards
• monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis and dealing with and solving any issues
• verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
• collect completed CRFs from hospitals and general practices
• write visit reports and file and collate trial documentation and reports
• meet with team members to discuss on-going trials, results and any trends or adverse events
• ensure all unused trial supplies are accounted for
• close down trial sites on completion of the trial
• discuss results with a medical statistician, who writes technical trial reports
• archive study documentation and correspondence
• prepare final reports and occasionally manuscripts for publication.

Salary

• Starting salaries for CRAs are in the region of £26,000 to £36,000. It's likely these posts will require some experience in a related area.
• As a senior CRA (SCRA), also known as a CRA II, you can earn a salary of £37,000 to £55,000.
• In some senior roles, as a manager or director, salaries in excess of £60,000 can be achieved.

Salaries vary between companies. Additional benefits, such as a car allowance and bonus and pension, are typically offered.

Income figures are intended as a guide only.

Working hours

Working hours can vary but you’ll typically work 37 to 40 hours across Monday to Friday. You should expect to work some evenings, although weekend or shift work is uncommon.

Part-time work is possible, as are career breaks. Short term contracts of six to twelve months with a company are common, meaning you may work more like a contractor than a permanent employee.

What to expect

• It's likely your role will be a mixture of desk-based office work and site visits. While trials are running, you may need to visit the site every four to six weeks. For some roles, the desk-based work may be carried out remotely from home.
• Some trials may be set up and run abroad meaning there would be the requirement for international travel.
• Jobs are available throughout the UK. Company laboratories can be found locally, whereas pharmaceutical companies tend to be based in the south of England.
• Self-employment or freelance work on a contract basis is possible once you've gained significant experience.
• The job can involve a lot of travelling and 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.
• Initiatives are in place to encourage more women into science-based careers, such as Women in STEM.

Qualifications

To become a clinical research associate (CRA) you'll need to have a degree in a life science, medical science or nursing subject.

Relevant degrees include:

• anatomy
• biochemistry
• biology
• biomedical science
• chemistry
• immunology
• medicine
• microbiology
• molecular biology
• pharmacology or pharmacy
• physiology
• toxicology.

Entry without a degree or with a HND only is unlikely. You might occasionally be able 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/assistant. However, you would need substantial experience and further qualifications to progress to the role of CRA.

A postgraduate qualification is not essential, with many employers only looking for a related undergraduate degree. However, a relevant Masters, such as an MSc in Clinical Trials, could give you an advantage against competition when applying for jobs.

A PhD can also be advantageous in some companies, who may consider it as highly-relevant work experience. It could also count towards gaining promotion to senior positions or moving into protocol development. Check with potential employers to find out what they're looking for.

Search for postgraduate courses in clinical research or clinical trials.

Skills

You'll need to have:

• excellent communication, both written and verbal, and interpersonal skills
• the ability to build effective relationships with trial centre staff and colleagues
• the ability to motivate others
• strong customer focus
• an excellent grasp of numeracy and a keen eye for detail
• presentation skills
• the ability to multitask and think on your feet
• project management skills
• a flexible and adaptable approach to work
• organisational, IT and administrative skills - the job involves a lot of documenting and recording information through computerised processes, such as clinical trial management systems and electronic data capture
• an understanding of the importance of good clinical practice (GCP), which is a legal requirement for all CRAs.

You'll usually need a driving licence for travel between trial sites.

Skills in an additional language, particularly any European ones, may also be useful for roles abroad.

Work experience

Relevant experience is crucial for securing a job as a CRA. Without it, you're likely to start work at a lower level, as a clinical data coordinator or clinical trials administrator/assistant and then will work your way up to a full CRA role.

Related work experience can include anything that uses scientific and analytical skills, for example:

• academic or pharmaceutical research
• clinical data work
• clinical laboratory work
• medical sales
• nursing or care work
• pharmacy.

Another useful way of gaining experience is to complete an industrial placement as part of your undergraduate degree. This can give you the real-world experience in a related area as well as helping you to make contacts that could lead to potential job offers in the future.

Competition for jobs is strong and work experience in a clinically-relevant field will considerably improve your chances.

Find out more about the different kinds of work experience and internships that are available.

Employers

Typical employers include pharmaceutical companies, medical device manufacturers, biotech companies and contract research organisations (CROs), which conduct research on behalf of pharmaceutical companies.

A CRO will organise the placement of a 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. As the CRA, you would report back to the CRO 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:

• BMJ Careers
• emedcareers
• New Scientist Jobs
• Pharmiweb Jobs

Contract research organisations and pharmaceutical companies may advertise vacancies on their own websites.

Specialist recruitment agencies also handle vacancies. These include AL Solutions and RBW Consulting.

Professional development

Training takes place mainly in-house and on the job. The nature of the training can vary from company to company, with some employers providing a structured system.

Some companies will pay for relevant external training courses through organisations such as the Institute of Clinical Research (ICR). They provide training in areas such as:

• advanced monitoring
• effective project management for clinical trials
• foundation in good clinical practice (GCP)
• vendor oversight in clinical trials
• essentials of clinical trial monitoring.

You may want to consider becoming a member of the ICR as it provides networking opportunities, discounted training, specialist interest groups and access to industry news. You can progress through the ICR membership levels but to do so you'll need to undertake a certain amount of continuing professional development (CPD) each year. This can be in the form of courses, conferences, workshops or self-directed learning such as reading industry press.

If you don't already have a postgraduate qualification, you can take a postgraduate certificate, diploma or Masters in areas such as:

• clinical pharmacology
• clinical pharmacy
• clinical research
• pharmaceutical medicine.

It's also possible to do a PhD. These courses can facilitate professional development and career advancement but you should check this against the career route you want to follow and employers of interest.

Career prospects

Career structures vary between employers. How quickly you move up the grades depends on a range of factors including motivation, the opportunities available for training and development, ability and previous experience.

Before becoming a CRA, you may begin at a lower level such as a clinical trial administrator or junior CRA. As a CRA (also known as a CRA I), you'll work on pre-trial procedures, setting up and organising clinical trial sites (with some supervision), archiving documents and correspondence.

With the right combination of skills and experience you can move into the role of senior CRA (SCRA), also known as a CRA II. Work will include selecting investigators, coordinating ethics committee and regulatory authority applications, supervising trial supplies and attending investigator meetings.

As you progress further you'll also be responsible for 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).

You could become a clinical team manager, clinical trial manager or clinical project manager depending on where your interests and skills lie. Beyond this are director roles within the same areas.

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 into a role directly with a pharmaceutical company.

Self-employment may be possible as CRAs are employed on a freelance basis by certain companies. This should usually only be considered when you have built up significant experience, contacts and clients.