I Want to Work In …Clinical Research and Regulatory Affairs
The Clinical Research Associate coordinates clinical trails of new drugs. Once these trials are successful, the Regulatory Affairs Officer takes the trial data and uses this to gain government approval for the new medicine. Both jobs are well paid and interesting.
- Clinical Research Associate
- Regulatory Affairs Officer
- Employers, recruitment agencies and job vacancy sites
- Job roles in the birth of a medicine
CRAs work for pharmaceutical companies and Contract Research Organisations which plan, organise and conduct Clinical Trials on behalf of pharmaceutical companies. Before the 1960s there were no regulations governing the safety and efficacy of drugs. The work of the CRA became important when the thalidomide drug tragedy occurred in the 1960s producing severe deformities in many babies. This lead to regulations which required detailed clinical trails on all new medicines.
CRA's are also called Clinical Trials Administrators (CTAs), Clinical Research Scientists, Clinical Secretaries, Clinical Trials Assistants, Clinical Trials Associates, Data Monitors and Clinical Research Monitors!
PROFILE: CLINICAL RESEARCH ASSOCIATE (CRA)/DATA MONITORCo-ordinates clinical trials carried out on new drugs on volunteer patients. THe work tends to divide between days in the office and days visiting trials:
Visiting trial sites:
EMPLOYERS: Employed by pharmaceutical companies, contract research organisations such as Innovex, Cancer Research UK which can focus on trials that would not be commercially viable, public sector bodies such as the Medical Research Council where pay is lower but pensions, holidays and job security are better.
DEGREE: life science or medically-related degree preferred. Some enter from nursing or with PhDs for senior posts
Attributes required by CRAs
In the past few years the percentage of clinical trials carried out in the UK has dropped as companies have increasingly carried out trials in Asia and Eastern Europe where it is cheaper. The cost of doing trials in the UK is one of the highest in Europe, but firms have in the past preferred to carry out trials in the UK because of our strong research base. The huge patient base of the NHS (over 50 million patient records) is also a powerful resource.
Bureaucracy in trial approvals has created longer start up times than in other European countries. This is important as the patent on a drug only runs for a limited number of years and once it expires, anyone can copy the drug. It is especially important for smaller companies to get trails up and running quickly to maintain cash flow from investors. A large trial may involve obtaining contracts with many different primary care trusts each one requiring its own set of paperwork. A UK Clinical Research Network has now been set up to speed up approval of trials and this seems to be working.
Many CRAs work for Clinical Research Organisations (CROs) who either provide extra staff for Clinical Trials to meet deadlines, or take on the whole trial themselves on behalf of the pharmaceutical company. CRAs working for CROs have to meet tight deadlines within tight budgets, but do gain a wide breadth of knowledge in a number of therapeutic areas.
Getting a job
Many posts for new entrants are not advertised, so you need to send a science style CV (but also emphasising the skills outlined above) with a speculative covering letter to employers who might recruit. See our creative jobhunting page for help with networking skills. Most new graduates will start as a trials assistant or data monitor initially.
One good starting point to gain some insight into the work of a CRA is to take part in a clinical trial yourself. Pay is up to £100 per day.
Kent Bioscience graduates have gained the following jobs in clinical research and regulatory affairs roles.It could be worth sending a speculative CV to some of these organisations about jobs.
- Clinical Data Co-ordinator/Analyst Luton NHS Trust, Quintiles, GSK, MDS Pharma.
- Clinical Research Associate: Orion Clinical
- Regulatory Affairs Executive: Orion Clinical
- Drugs Trials Monitor: Icon Clinical Research
- Market Researcher: Data Monitor
- Marketing Assistant: Reaction/Wamnet
- Clinical Safety Assistant.: Novartis
- Planning Co-ordinator: GSK
Questions you may be asked at interview
- Why do you want to be a CRA?
- What do you know about the role?
- What attributes have you got that would make you suitable for the job?
- What are the phases in the clinical research process?
- Give an example of where you have had to successfully juggle several tasks at once.
- Give an example of a situation when you had to persuade someone to change their mind.
- What does ABPI stand for?
- What does GCP stand for?
Master's Degrees in Clinical Research are available at Cardiff, Surrey and Cranfield Universities
Clinical Trials Project Managers - Quintiles Laboratories, Scotland
www.quintiles.com With more than 30,000 employees working in approximately 100 countries, Quintiles has helped develop or commercialise 100% of the top-100, best-selling drugs on the market in 2013. QLAB is the world’s largest network of wholly-owned, CAP accredited laboratories. We collaborate with our customers in the pharmaceutical and biotechnology industries to deliver a wide range of laboratory based solutions as part of their global clinical trial programmes. With our mix of clinical, operational, and scientific expertise, our team delivers clean, reliable, and comparable lab data which can be used to improve our customer’s probability of success. Our Project Managers work with our customers every step of the way. Our Project Managers’ goal - to ensure an easy, seamless study start-up, implementation, monitoring and close-out. Our QGrADS website and application process will open on 12th January 2015 and close 28th February 2015. For acceptance on to our QGrADS programme, you will be on course for a minimum 2:1 honours degree, Masters or PhD in a life sciences or business management degree. Of equal importance to your academic record will be the ability to demonstrate an unwavering commitment to a Project Management career within the clinical trials or pharmaceutical industry. This could either be through the successful completion of an internship or industrial placement, professional work experience or even related part-time work.
Clinical Trials and Regulatory Affairs Training for Life Science Graduates
Clinical Professionals train talented Life Sciences University Graduates within the UK and deploys them into “first to industry” clinical roles via a Graduate Training Academy
Clinical Professionals has developed an industry leading training program for Life Sciences Graduates wishing to embark on their first to industry role in Life Sciences/pharma. The training courses are set up for graduates wishing to pursue a career within clinical trial research. The entry point starts with Clinical Trials Administrator (CTA) and offers a career gateway through to Directorship level roles. Clinical Professionals is recruiting for Life Science graduates with a minimum 2:1 in their chosen Life Sciences degree with exceptional communication skills. You must be an individual committed to finding a role within clinical trial research. For those successful graduates entering our program we will offer a free and comprehensive training program with a view to then finding you your first to industry role with one of our global pharmaceutical or CRO clients. We will then support you for the first 12 months in the field with further training and personal development:The course will include:
- History of clinical trials and compound life cycle
- Clinical trial terminology and design
- Ethics, morals and the importance of subjects/patients
- Regulatory affairs, ICH GCP
- Protocols and patient safety, Trial Master File
- Patient Information sheet and informed consent, recruitment and retention
- Drug supplies and patient safety
- Trial Documentation, trial structure, monitoring and study close out
- Quality assurance, audit and inspection
- A day in the life of a Clinical Research Associate
- Interview and CV preparation
- Once placed in your role we will work with you in your role to offer continued professional development and ongoing career opportunities
Clinical Professionals is a leading Life Sciences staffing business. We have limited spaces for our April and June intakes. In the first instance please email email@example.com with your CV and reason for wishing to included on this exceptional training scheme. The April and June courses will be based in the south east.
- Institute of Clinical Research www.icr-global.org
- Controlled Trials www.controlled-trials.com – links to clinical trials sites and clinical research jobs
- Association of the British Pharmaceutical Industry http://careers.abpi.org.uk/your-career/Pages/default.aspx
- Medical Research Council www.mrc.ac.uk
- Prospects Occupational Profile for Clinical Research Associate www.prospects.ac.uk/links/ClinResAss
- Clinical trials and their patients: The rising costs and how to stem the loss
Regulatory Affairs is a comparatively new profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Regulatory Affairs Officers work for pharmaceutical companies advising and coordinating application procedures for the approval of new medicines and chemicals with respect to safety in use, transport and storage world-wide. Their work involves compiling vast dossiers of information on a new drug and submitting it to a national regulatory authority for approval in order to gain permission to sell the drug.
Typical work activities
- Keeping abreast of world-wide legislation.
- Advising scientists about regulatory requirements.
- Writing and preparing documentation for approval by regulatory bodies.
- Liaising with and making presentations to registration authorities.
- Maintaining existing product licences and liaising with authorities over changes to labeling and packaging.
- Good writing skills
- Attention to detail
- Able to communicate confidently
- Computer literacy especially databases
- Awareness of legislation on approval of products desirable.
- Senior staff have to make presentations to regulatory bodies
Recruitment is erratic so make speculative applications to pharmaceutical companies.
- For further information on this career, training and employers, see the following links:
- Prospects profile of a Regulatory Affairs Officer www.prospects.ac.uk/regulatory_affairs_officer.htm
- Target Jobs profile http://targetjobs.co.uk/careers-advice/a-to-z-of-careers/regulatory-affairs-officer
- TOPRA (The Organisation for Professionals in Regulatory Affairs) www.topra.org
- Association of the British Pharmaceutical Industry (ABPI) www.abpi.org.uk The ABPI is the trade association for more than 70 companies in the UK producing prescription medicines. The ABPI page on Regulatory Affairs is at http://careers.abpi.org.uk/working-in-the-industry/research/Pages/regulatory-affairs.aspx
- Careers in Regulatory Affairs: an article by Dr Stephen Thompson
- Vacancies for jobs are often found in New Scientist www.newscientistjobs.com/graduate
- ICON plc www.iconplc.com
- NorthWise Services www.northwiseservices.com range of services and products to the pharmaceutical and biotechnology industries, in support of the clinical trial process including data management, statistics and medical writing.
- ORION Clinical Services www.orioncro.com/careers runs clinical trials on behalf of pharmaceutical companies. Have recruited several Kent bioscience graduates
- Parexel http://jobs.parexel.com positions available in the UK and around the world including data monitor and CRA
- Quintiles Innovex www.quintiles.com/careers recruits people into the healthcare sales sector, including medical sales and clinical research.
- Star Medical www.starmedical.co.uk/clinical-jobs clinical research jobs. Also useful page on getting started in a Clinical Research career
- SRG Interesource www.srgclinical.com clinical trials and regulatory affairs recruitment
- Trac Services www.tracservices.co.uk/company-profile/careers Regulatory Affairs consultancy
Clinical Trials consist of five phases
Last fully updated 2013