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

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 MONITOR

Co-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:
  • Set the trial up in hospitals or GP surgeries, ensure the smooth running of the trial.
  • Regular visits to site to ensure data captured is accurate and to collect the data when completed.
  • Recruitment of investigators, initiation, monitoring and close-down of centres.
  • Liaising with NHS doctors and researchers at the site of the trial
  • Monitoring progress of trials.
  • Meeting with the study staff to sort them out any problems
  • Ensuring that the data recorded for the trial is accurate and verifying it against the patients' notes. Checking case record forms for missing data and inconsistencies.
  • Tracking patient's samples
  • Making sure that supplies at the centre are adequate. Carrying out accountability for any study medication.
In the office or at home:
  • Making phone contacts with centres and investigators;
  • Writing-up trial visit reports;
  • Updating status databases;
  • Preparing for visits; and attending project meetings
  • Maintaining contact lists
  • Writing trial protocol why the trial is being conducted, by whom and how it will be performed.
    The study must minimise bias by use of , for example, placebos and double blind trials.
  • Finding suitable clinicians to conduct the trial and briefs them.
  • Preparing documentation and supplies.
  • Initiating study centres.
  • Coordinating ethical and regulatory submissions
  • Processing payments to consultants
  • Answering queries.
  • Discussing results with statisticians.
Level 1 CRAs assist with the administration of trails, and level 2 CRAs coordinate the trails
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.
SATISFACTIONS:
  • Huge amount of variety, so many people stay in the job for a long time as you don't get into a rut.
  • Very people orientated.
  • Can control the hours you work, so a good job if you have a family.
  • Some travel abroad for international companies.
  • May be able to work from home.
NEGATIVES:
  • Lot of travel between trial sites including overnight stays.
  • Tight deadlines.
  • Lots of pressure.
  • Often looking after several trials at once: demands good time management.

DEGREE: life science or medically-related degree preferred. Some enter from nursing or with PhDs for senior posts
TRAINING: The Institute of Clinical Research runs accredited courses which employers normally pay for.
TIPS: May be difficult to enter immediately on graduating and graduates often start as data monitors/trials assistants before moving on to the full CRA role. Work experience in a related clinical field (e.g. medical sales or laboratory work) would help. Evidence of good organisational and admin. skills vital. Recruitment levels are high in contract research organisations as pharmaceutical companies increasingly outsource this role. Salaries are good, with trainees earning £24k plus and experienced CRAs earning over £40k.

Attributes required by CRAs

  • Attention to detail
  • Multi-tasking: you often work on several different trials at one time.
  • Flexibility and adaptability
  • Time Management.
  • Computing skills
  • Driving
  • Enjoyment of travel. You regularly get out of the office to visit trials.


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 with organisations such as Trials4us, Hammersmith Medicines Research, ICON Development Solutions (Manchester), Roche and GSK Clinical Trials

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.

Questions you may be asked at interview

 

Master's Degrees in Clinical Research are available at Cardiff, Surrey and Cranfield Universities

Further Information

REGULATORY AFFAIRS OFFICER

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

Skills required

 Recruitment is erratic so make speculative applications to pharmaceutical companies.

FURTHER INFORMATION

 

Employers, recruitment agencies and job vacancy sites

 

Clinical Trials Careers Chart

Clinical Trials consist of five phases

  • Pre-clinical: in vitro (test tube) and animal tests, to determine dosing and any potential risks to administration in humans.
  • Phase I: the determination of safe doses of a new drug by trials on healthy human volunteers and the drug's effect on the body (pharmacodynamics) and the body's effect on the drug (pharmokinetics). Often performed in large teaching hospitals or by Contract Research Organisations (CROs)
  • Phase II: Determination of therapeutic efficacy and safety by testing on small numbers of patients. The researcher wants to determine whether the treatment works effectively.
  • Phase III: Studies with large numbers of patients undertaken in hospital or by GPs. Comparison of the efficiency and side effects of the drug with existing treatments and placebos.
  • Phase IV Carried out after the product licence has been granted by the regulatory authorities. Large, long term epidemiological studies conducted by the industry to assess optimal use. These are important for the marketing strategy of the drug. Post marketing surveillance studies continue to monitor safety (pharmacovigilance)

 

Also see our science writing page and our science careers pages

 

Last fully updated 2011