Profile of a Clinical Quality Assurance Auditor - Clinical Quality Assurance - ADAMAS Consulting UK, USA, Europe & Worldwide

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Profile of a Clinical Quality Assurance Auditor

To most people in the Pharmaceutical Industry the idea of the generalised audit has changed completely. Initially having an uncommunicative and destructively critical reputation, the modern CQA auditor has had to develop a much more rounded personality. This has been driven by the need of both pharmaceutical companies and CROs for a massive improvement in their systems and practices to keep in step with the rapidly changing and demanding regulatory framework within which clinical trials are conducted. An auditor is now required to be able to remain objective, while having a great commitment to the company for whom he/she works. It is then possible to review systems, comment on their shortcomings constructively, maintain the trust of their colleagues, and help senior management find the best course for improvement.

When selecting suitable candidates for their QA department most companies will have the same core requirements with a number of peripherals that are a real bonus. The relative importance of these varies from company to company while also depending on the exact nature of the role required. These characteristics are listed below, and even then may well depend on the background of the candidate being selected.

Qualifications (minimum)	BSc or equivalent in a life science
Experience	Working in Clinical Research, but at the very minimum in a scientific or medical background. Working to SOPs and industry regulations is also a definite benefit.
Knowledge (Ideally)	ICH GCP guidelines FDA Code of Federal Regulations Clinical Research Process
Characteristics	Highly professional Oral and written communication skills Self-motivated Self-confident Integrity Able to work independently while being a good team player Able to concentrate on the detail without losing sight of the overall picture
Skills	Diplomatic Highly organised Attention to detail Problem solving Presentation Computer literate

It is probably fair to say that no one has all of these characteristics and skills, and many will have some that are not mentioned here. If you feel that you measure up well to a majority of the list above perhaps you should consider a career in Clinical Quality Assurance. It is a position that provides great variety, the opportunity of meeting a wide range of people and one that gives you the feeling that your efforts will make a difference.

“Thank you again for all your work done during the audit. I appreciate very much all your comments, suggestions & solutions that you raised during the audit finding. Your visit is obviously a great experience for investigators and myself, an identification of certain findings helps in more accurate and efficient conduct of this study.”
MJ, Clinical Research Manager, International CRO