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. CTA's work for pharmaceutical companies and Contract Research Organisations which plan, organise and conduct Clinical Trials on behalf of pharmaceutical companies.

CRA's are also called Clinical Trials Administrators (CTAs), Clinical Secretaries, Clinical Trials assistants, Clinical Trials Associates and Data Monitors.

PROFILE: CLINICAL RESEARCH ASSOCIATE (CRA)/DATA MONITOR

Co-ordinates clinical trials carried out on new drugs on volunteer patients.
  • Liaises with NHS doctors and researchers at the site of the trial.
  • Maintains contact lists
  • Writes trial protocol(details of what is to be done, by whom and how).
  • Finds suitable clinicians to conduct the trial.
  • Prepares documentation and supplies.
  • Initiates study centres.
  • Helps to develop protocols.
  • Coordinates ethical and regulatory submissions
  • Monitors progress of trials. Tracks patient's samples and case reports
  • Processes payments to consultants
  • Answers queries. Checks and collects patient data from the patient files.
  • Discusses results with statisticians.
  • Writes trial reports.
  • Archives information

Level 1 CRA's 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.
NEGATIVES: Lot of travel between trial sites including overnight stays. Tight deadlines. Lots of pressure. Often looking after a number of different trials at once which demands good time management skills.
SKILLS: communication, organising, time management, persuasiveness. An outgoing, confident personality is essential.
DEGREE: science or medically-related degree preferred
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.

Skills required

 

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

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.
  • Phase II: Determination of therapeutic efficacy by testing on patients. The researcher wants to determine whether the treatment works effectively.
  • Phase III: Comparison of the efficiency and side effects of the drug with existing treatments and placebos.
  • Phase IV Large, long term epidemiological studies conducted by industry carried out after approval by the regulatory authorities and marketing, to assess optimal use

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.

REGULATORY AFFAIRS OFFICER

Works for pharmaceutical companies to get approval for new medicines. Advises and co-ordinates application procedures for the approval of drugs and chemicals with respect to safety in use, transport and storage world-wide. 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. Preparing and documentation. Liaising with and making presentations to registration authorities.

Skills required

 

Recruitment is erratic so make speculative applications to chemical and pharmaceutical companies.

FURTHER INFORMATION

 

Also see our science writing page and our science careers pages

 

Last fully updated June 2009