The Job and What's Involved
Each year, many new medicines are developed to treat a range of medical problems from common illnesses to life-threatening diseases such as HIV, cancer and diabetes. At the same time, existing medicines have to be tested or undergo trials (known as clinical research) to ensure they are safe. Trials need to be carried out before a product reaches a hospital or the shelves of the local pharmacy. Clinical research is the scientific study of the risks, effectiveness and benefits of these medical products.
A clinical research associate (CRA) is responsible for setting up, monitoring and completing clinical trials. A CRA may also be called a clinical research (or trials) monitor, clinical research executive, scientist or co-ordinator, depending on the employer.
Clinical trials are conducted by pharmaceutical companies or by research organisations known as contract research organisations (CROs) that conduct trials on behalf of pharmaceutical companies.
Clinical research includes:
- Trials on healthy humans to study the safety of products.
- A study on a small number of people, e.g. patients in a hospital, to test for safety and the level of dose required.
- Studies on larger groups of patients to look for side effects and to check whether or not the new medicine is better than existing treatments.
- Further studies at or after the launch of the new product to see if the medicine can be used for other conditions or for different groups of patients, such as children.
On average, it takes 12 years to develop a new medicine, and adequate clinical trials are an important part of gaining marketing approval.
The job may involve:
- Liasing with doctors and consultants about conducting trials.
- Finding a suitable study centre, which may be at a hospital or health centre.
- Setting up the study centre and ensuring it has the right resources and study materials.
- Designing case record forms (CRFs).
- Developing protocols to collect and transmit the data.
- Monitoring the trial, collecting suitable data and confirming its accuracy.
- Writing reports on the results.
- Co-ordinating applications and reporting back to an ethics committee that safeguards the rights, safety and well-being of people in the trial, as well as to regulatory authorities that oversee the research and the marketing of new and existing drugs.
In some companies, the CRA may be involved in the whole process, from discussing the initial idea to undertaking analysis and writing up reports. In other companies, the work may only involve collecting data and confirming results once the trial has been set up. CRAs are generally employed at one of three levels:
Level 1 involves visiting investigating centres, setting up, organising and administering the clinical trial, and liasing with centre staff.
Level 2 has more involvement with other activities such as protocol development, design of case record forms and writing research reports.
Level 3 has more involvement with the management of projects.
CRAs usually work standard office hours from Monday to Friday although hours vary between companies. Working additional hours in the evening is common.
CRAs may work alone or in teams. They can be office-based, field-based or work from home. Field-based CRAs work mainly on the road, visiting trial centres such as hospitals and doctors' surgeries. This may require a lot of traveling, sometimes abroad, and involve being away from home for three or four days a week.
The work requires a smart appearance and a CRA must have a clean driving licence.
The starting salary for a CRA is around £20,000 a year. Experienced associates can expect to earn up to £40,000.
The highest salaries are in the region of £50,000 a year.
A car is often provided and bonuses may be paid.
Getting Started with this Career Choice
CRAs are employed by pharmaceutical companies and contract research organisations (CROs). There is a concentration of such companies in southern England but field-based positions may be found across the UK. A small number of CRAs work for hospital trusts in clinical trials units. Competition for jobs is fierce, particularly for graduates with no relevant experience. With qualifications and experience, however, prospects are good.
The constant tightening of government regulations on the licensing of new drugs and re-licensing of existing drugs means that the need for CRAs is increasing.
Vacancies may be advertised in journals such as CRfocus, New Scientist and The Pharmaceutical Journal. They may also be advertised on the websites of pharmaceutical companies, contract research organisations (CROs), specialist recruitment agencies and The Institute of Clinical Research (ICR).
Education and Training
The normal minimum entry requirement is a relevant degree. This may be in a life science, such as pharmacology, pharmacy, biochemistry, physiology or toxicology. It may be in a medical science, such as nursing, medicine or dentistry. The minimum requirements for entry to a degree course are usually two A levels and five GCSE's (A*-C) or equivalent qualifications. Those without the usual qualifications can take an Access course.
A postgraduate qualification may be useful when seeking entry as a CRA. There are a small number of Masters degree and diploma courses that include elements of clinical research. It is an advantage with some companies to have a relevant PhD, both to gain entry and for promotion, and it is worth checking postgraduate study routes with potential employers. Entry to postgraduate study is usually with at least an upper second class honours degree.
Previous relevant experience is helpful. This could include nursing, pharmacy, medical sales, clinical laboratory work, clinical data work and academic or pharmaceutical research. Graduates without relevant experience are, in most cases, likely to have to enter the field at a lower level, e.g. as a clinical data co-ordinator or clinical trials administrator. With experience gained at this level they may progress to working as a CRA.
The ICR offers eLearning modules for potential CRAs, which include an exam and offer a certificate showing successful completion.
A Few More Exams You Might Need
Training normally consists of in-house training and access to external courses. It is likely to include clinical skills and data management skills, standard operating procedures, ethical and quality issues, personal development and IT skills. Training also includes Good Clinical Practice (GCP), which is now law throughout Europe.
Some organisations run CRA trainee schemes to help new graduates into the field of research. The schemes combine classroom teaching with practical experience gained with an employer. After a training period that may last for three months or more, the trainee may be offered a full-time post by the employer.
Some companies offer block or day release to study for qualifications such as a Masters degree or postgraduate diploma. These are available at: Liverpool John Moores university and at the universities of Cranfield, Cardiff, Glamorgan and Surrey.
Continuing professional development (CPD) is important for CRAs and the ICR has a CPD scheme. CPD activities can include postgraduate study, professional examinations, private research and attending conferences. Some ICR members become chartered scientists.
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Skills and Personal Qualities Needed
A CRA should:
- Have excellent communication skills, both written and oral.
- Be able to work well in a team or individually.
- Be able to motivate others.
- Be well organised and able to multi-task, as the work may involve managing several trials at the same time.
- Have an eye for detail.
- Have commercial awareness.
- Have a mature and responsible attitude.
- Be confident, tactful and diplomatic.
- Understand the importance of good clinical practice.
Your Long Term Prospects
Career progression involves moving up to the next level to jobs involving the design and management of trials. Experience can be built up by working for a variety of pharmaceutical companies in different areas and different phases of clinical research.
Self-employment is possible, as some companies employ CRAs on a freelance basis.
Get Further Information
The Association of the British Pharmaceutical Industry (ABPI),
12 Whitehall, London SW1A 2DY
Tel: 0870 890 4333
Websites: www.abpi.org.uk and www.abpicareers.org.uk
The Institute of Clinical Research (ICR),
Institute House, Boston Drive, Bourne End, Buckinghamshire SL8 5YS
Tel: 0845 521 0056
Website: www.icr-global.org
NHS Careers (England),
PO Box 2311, Bristol BS2 2ZX
Tel: 0845 606 0655
Website: www.nhscareers.nhs.uk
Royal Pharmaceutical Society of Great Britain (RPSGB),
1 Lambeth High Street,
London SE1 7JN
Tel: 020 7735 9141
Website: www.pharmacycareers.org.uk
Skills for Health,
2nd Floor,
Goldsmiths House,
Broad Plain,
Bristol BS2 0JP
Tel: 0117 922 1155
Website: www.skillsforhealth.org.uk