Clinical Research quality assurance

CLINICAL RESEARCH QUALITY ASSURANCE


For a career in clinical research quality assurance, agreement with internal, national and international regulations in every aspect of clinical development is absolutely essential. Serious setbacks can be dangerous for patients, extremely costly and highly damaging to a company’s reputation, they set 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, though it can be a tricky area to get into. Such positions are not ‘siloed’ in the way many other roles can be, a career in CQA could be an eye-opener to all aspects of the clinical trials process, many different therapeutic areas and types of organizations.


Just as in clinical operations, as your career develops you will normally become more office based, seeing to the work of audit teams, developing audit strategies and plans and ensuring a culture of compliance in your own organization as well as the ones you’re in partnership with. You will also gain exposure to other areas of QA, such as Good Pharmacovigilance Practice (GPvP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). Experience in more than one QA specialism will make you more attractive to potential employers. GPvP experience is particularly sought after these days.


Many people choose to go down the interim path as their QA careers develop, tending to opt for either short-term, ad-hoc work to complete individual projects for a range of clients or to take longer-term contracts that offer more security but at a lower pay rate.


Personality type is crucial to success in the CQA world. Thankfully the days of the QA group being seen as ‘them’ in most companies are long gone. Compliance is about getting people to work together and according to the correct procedures in order to complete successful studies. You will be expected to train staff from a wide variety of disciplines, answer QA related queries and, on occasion, deal with some difficult situations. Very strong interpersonal and communications skills, a high degree of tact and knowledge in different areas is essential.


HOW MUCH DOES A CLINICAL QUALITY ASSURANCE MANAGER MAKE?

The national average salary for a Clinical Quality Assurance Manager is $98,393. Salary estimates are based on 4,654 salaries submitted anonymously by Clinical Quality Assurance Manager employees.

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Kylie JamieComment