Clinical Research Quality Assurance

May 19

For a career in clinical research quality assurance, understanding internal, national and international regulations in every aspect of clinical development is absolutely essential. Legal setbacks can be dangerous for patients, extremely costly, and highly damaging to a company’s reputation. Therefore, the role of the Good Clinical Practice QA professional is a high profile one and can offer excellent opportunities for development. However, it can be a tricky area to get into.

Just as in clinical operations, as your QA 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 specialization will make you more attractive to potential employers. For instance, GPvP experience is particularly sought after these days.

Many people choose to go down the interim path as their QA careers develop, opting 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.

The right personality is crucial to success in the QA world. Thankfully the days of QA groups being seen as ‘other’ in most companies are long gone.

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 to the job.

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.

Take courses from CCRPS and learn more on how to become a clinical research assurance manager.

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