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The Role of the Clinical Auditor in...

1. Pharmaceutical Companies
The Clinical Quality Assurance departments within pharmaceutical companies can vary enormously in the number of auditors, the roles, responsibilities and reporting lines. Some companies employ a QA Manager who contracts out all of the audits and is mainly responsible for coordination and monitoring of the contractors. Other companies retain all of their QA staff in-house and conduct all of the necessary audits themselves without external support.

QA groups can vary in size from one person to over one hundred within a company. The auditors' responsibilities also vary between organisations. In some companies the auditors work on a local level, in others the auditors work on a world-wide basis. In large departments the auditors may specialise in one or two types of audit only, such as Investigator Site audits or Clinical Report audits. Before accepting a position within a pharmaceutical company it is recommended that you determine the size and function of the QA group and also the responsibilities of auditors.

The advantages of working within a pharmaceutical company are that you become familiar with the specific compounds under development, you know the SOPs and also the people conducting the studies. You can have significant input into process improvement, and you can follow up audit recommendations more effectively. Clinical QA generally reports into a senior management level and therefore has a high profile within the organisation and can be highly influential. It is possible to build constructive and positive relationships with the Clinical Development department, which adds to job satisfaction.

2. Contract Research Organisations
The Contract Research Organisation (CRO) makes different demands on their CQA Department. Large CROs, like large pharmaceutical companies may well have a large number of auditors in their QA department. Their roles can be amalgamated into two areas; firstly auditing studies under contract to the sponsor company. This will usually involve the audit of a specified part of a clinical trial and will be paid for by the sponsor. Occasionally the QA department will be asked to audit a third party when an independent review is required. The second area is ensuring that the company processes that are being used to run the CRO and its contracted work are of a high standard. This area will include a large number of system audits, audits of trial processes where the sponsor is not paying for the QA activities, and assisting in preparation for inspections and customer audits.

In medium and small sized CROs you will certainly need to be able to turn your hand to almost all aspects of QA. Some large CROs have departments in which each auditor has a specialised area in which to work, but this is not always the case. You should ensure that you are aware of the actual requirements of a post before accepting it. Normally the QA department will report to senior management so that their independence from those managing the clinical trial processes is clear to potential customers.

There are a number of advantages in working in a CRO. First, there is the variety you will encounter. You will conduct a wide range of audits in a variety of therapeutic areas, you will also perform a number of system audits and through them have the opportunity of shaping the modus operandi of the whole company. In addition, the need to complete contracts on time and within budget while maintaining the highest standards of quality, give the work a real edge.

3. Consultancies
Most of the consultancies involve sole-traders, but a few involve a team of consultants with a variety of specialist skills. In order to work as a consultant it is necessary to have several years of experience within Clinical Research and/or Clinical QA. However, some consultancy firms employ less experienced people and train them to become consultants.

The role of a consultant is similar to the role of a contract clinical auditor, in that you are hired by an organisation to conduct audits on their behalf. The client company might require you to work to their SOPs, or to work to your own SOPs (which is more common). As a consultant you might be asked to conduct any type of audit including possible fraud and misconduct audits, in any part of the world. Therefore, you need to be prepared for every eventuality, and maturity and experience help in dealing with this.

As a consultant you can gain a broad experience of clinical QA within a short period of time. However, you have to dedicate time to maintaining your knowledge of regulatory changes within the GCP environment, as well as building client relationships. In addition, there is a heavy administration burden, particularly for sole-traders in running a business.

The consultancy environment is different to the pharmaceutical company environment as you have to work to pre-defined and usually short timelines. Consultancies charge clients a daily or hourly rate and each task has an allocated amount of time. Exceeding time limits means that the consultant earns less money for the contract. The combined pressure of timelines and diversity of tasks makes the consultancy role a very challenging and demanding one.

“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