A clinical practice Quality Assurance role is a high profile job that can offer excellent opportunities for development as well as very good salaries, however, it can be quite a tricky area to get into.
Jim Gleeson, a Clinical Manager and Recruitment Specialist has written a short article outlining the best and most effective career paths for aspiring professionals who wish to get into QA. Take a look at Jim’s article here:
Compliance with internal, national and international regulations in every aspect of clinical development is absolutely essential. Serious failures can be dangerous for patients, extremely costly and highly damaging to a company’s reputation plus they tend to attract a lot of publicity. Therefore, the role of the Good Clinical Practice QA professional is a high profile one and can offer excellent opportunities for development. Such positions are not ‘siloed’ in the way many other roles can be, a career in CQA can give exposure to all aspects of the clinical trials process, many different therapeutic areas and types of organisations.
Those working in GCP QA will typically have a life science or nursing degree and a background in clinical operations, such as experience as a Clinical Research Associate or Project Manager, so they will have practical experience of having performed many aspects of the activities that are to be audited. A CRA’s monitoring experience will put them in good stead for the typical entry level role of GCP QA Auditor. Like a CRA, this can be a very ‘on the road’ position, involving travel to a variety of sites, often internationally. There are very many aspects of a clinical trial that need to be looked at, not only the obvious ones such as the documentation, investigator sites, manufacturing and packaging but also functions such as laboratory analysis, biometrics and translation services, often performed by third party suppliers. Another key duty is the hosting of inspections by regulatory authorities such as the MHRA and FDA. This will involve ensuring that all staff and process are suitably prepared beforehand, hosting the inspection itself, subsequent liaison regarding the results and management of any corrective actions required.
This article is one of our Drug Discovery and Development spotlight which aims to highlight the vast range of roles available in this sector such as medical affairs, quality assurance, clinical operations and drug safety, along with tips on job hunting, CV’s and interviews. If you would like to find out more click here