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Clinical Auditing as a Career

Are you a CRA seeking a new challenge? Do you want a job that has variety, would make use of your skills and that will take you all over the world? Then you should consider International Clinical Quality Assurance!

What can the industry do to attract more clinical research personnel into Clinical Quality Assurance (CQA)? Having recently conducted a survey amongst CRAs on their experience of audits (to be published), I was quite surprised by the positive attitudes expressed. However, there were a few who still perceive auditors as checking up on their work, nit-picking or time-wasting. If the overall impression is positive, why are more CRAs not moving into CQA? There are plenty of opportunities available, but the perception of the role is often negative.

The days of clinical auditors who have little clinical research experience, behave like Police, and spend their time reading through mounds of documents to find the odd typo, have gone for good! The role of the clinical auditor has expanded dramatically in the last five years and has developed into a more consultative role adding immense value to the clinical development process.

Clinical auditors can become involved in all aspects of clinical research from protocol development to the final clinical report and regulatory submissions. This may involve working across many therapeutic areas, in different phases of development and in several countries. Additional areas in which clinical auditors are becoming more involved are in Computer System development, Electronic Data Capture systems and proactive CRO selection.

In most organisations the limited amount of CQA resource is starting to focus more on the systems and processes involved in clinical development. The auditors review what is actually done and how it compares with the SOPs, and advise on changes to make the process more compliant with the guidelines/regulations as well as more efficient. Contrary to popular belief, auditors believe in making processes as simple as possible, as this reduces the potential number of errors occurring.

Quality assurance (QA) should not be confused with quality control (QC). Quality control is the responsibility of the people carrying out the work, such as the monitor, investigator or data manager. QA encompasses QC and audit, however the audit is a check of whether QC has been performed as required, and that the outcome of a process is correct, where a sample of documentation/data is checked.

In addition to their auditing function, most auditors offer many other services to clinical development. The types of additional services that the CQA function might offer are: GCP training for monitors and investigators, feedback of audit findings, GCP advice and problem-solving - as well as a shoulder to cry on!

Have you got what it takes to be a clinical auditor?

Excellent communication and interpersonal skills
Ability to identify and offer solutions to problems in a pragmatic way
Ability to see 'the big picture'
Good practical knowledge of GCP
Self-confidence and assertiveness
Ability to assimilate and analyse information rapidly
Interest in travel
Confidence to work alone or in a team

If the role sounds interesting to you, what do you need to become a clinical auditor? The majority of clinical auditors in the pharmaceutical industry (87%) have a life sciences degree, with approximately 20% having a MSc or PhD. Therefore, the entry requirements are similar to those for CRAs. However, most organisations are looking for experienced individuals whether they are from GLP/GMP QA or clinical research. In order to have the necessary credibility as an auditor, experience and maturity (not necessarily age, but personality) are essential.

If you believe you have what it takes, then investigate the opportunities for moving into clinical QA. The British Association of Research Quality Assurance (BARQA) can provide you with information on becoming a clinical auditor, as well as providing the latest survey on salaries and benefits in the profession!

“Thank you for such a positive and constructive audit and explaining difficult findings in a way that we can accept.”
A.P., Unit Director, Phase 1 Unit, US-based CRO