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Working in Clinical Trials January 18, 2010

Posted by qmresearchers in Career Talks.

 Last week I attended a careers talk given by Ian Gravenor, Senior Project Manager at Novo Nordisk Ltd.  Ian has a degree in Microbiology, a PhD in immunology and did two postdoctoral positions before entering industry.

Ian discussed the different phases of clinical trials and how it is important to understand what these are if you would like to work in this area.  Sounds obvious, but he suggested than many people at interviews do not know about the different phases of drug trials.

He listed the different roles within clinical trials which are:

Clinical Trials Administrator (CTA): This role often involves a lot of travel and the CTA represents the face of the company interacting with doctors and nurses at all the hospitals where the trial is being conducted. They have access to patient notes and need to ensure that the case report forms coincide with the patient’s hospital case notes.

Clinical Research Associate (CRA): A CRA sets up, monitors and completes clinical trials.

Project Manager: The project manager ensures that the trial runs within budget and that various milestones are met.  They are responsible for looking after the CTAs and liaising with ethics departments. A project manager needs to be a good problem solver, flexible and have good communication skills.

Auditors: These are the policemen of the team and ensure that procedures are being followed.

Medical Writers: These people write up all the results, safety data etc for reports.

Regulatory Affairs: Regulatory affairs officers ensure the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products.

There also roles for medics and  health economists as well as roles in marketing and business development.  

Ian said that it is very difficult to ‘break into’ clinical trials without any experience but it is possible. Here are the tips that he gave:

Tips on Getting in

  1. Learn about Good Clinical Practice (GCP) and the various phases of a clinical trial. Be aware of documents such as ‘The Declaration of Helsinki.’ Look at websites such as Institute of Clinical Research and Medicines and Healthcare Products Regulatory Agency.
  2. Think about joining professional bodies like the Institute of Clinical Research (ICR). Look at their site and keep up to date with what is happening. Joining such bodies illustrates a genuine interest in the field.
  3. Send out speculative letters and CVs to companies. You may have to be persistent and thick-skinned as this is not always immediately successful. Make sure your CV and covering letters are free of errors especially as CRAs are expected to have an eye for detail.
  4. Sign up with agencies that deal with clinical trials.
  5. Be flexible. You may have to start out as a CTA in order to become established in the field.
  6. Speak to people working in the industry to build your network. It is often easier to get into the industry if you know someone and your CV lands on the right desk!
  7. Think about working in a Contract Research Organisation (CRO) rather than just focussing on big pharmaceutical companies. CROs can be more fast-moving than bigger pharmaceuticals but you may get a broader range of experiences in a shorter space of time.

So, the same careers advice as usual really. Do some thorough research into the area, speak to as many people as possible in the field, do a great CV and circulate it to as many people as possible (in the relevant field, if you can), be flexible and be keep trying!



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