A Clinical Quality Assurance department is responsible for the overall quality of work for the entire organization.
QA personnel audit all processes and systems used in a clinical trial to ensure that all standard operating procedures are followed and that the organization is in compliance with all applicable regulations and guidelines. QA professionals also conduct staff training on various processes and QA policies.
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Quality Assurance (QA) is of paramount importance in clinical trials and clinical research at large. It is the systematic and independent evaluation of all trial-related activities and documents. Audits are conducted to find out whether the clinical trials were appropriately conducted as per the applicable standards, guidelines and regulations. Having Quality Assurance (QA) and Quality Control (QC) in place ensures the reliability, accuracy and the credibility of information and data generated in clinical trials. Purpose of Quality Assurance is not to ensure that the data gathered and analyzed is 100% error-free. Rather its purpose is to ensure that the clinical trials that are carried out are reliable which means that observed treatments’ effects are realistic and their estimated magnitude is unbiased.
Quality Assurance is a fundamental function within the clinical research industry and is primarily carried out by Clinical Quality Auditors. They are professionals highly experienced in clinical research and well versed with all guidelines and regulations applicable to clinical research. Not only do Clinical Quality Auditors audit clinical trials but by being a part of quality assurance departments they are also responsible for maintenance of the systems and processes within the organization. They ensure that processes being followed within their organization are in compliance with all applicable regulations. Clinical Quality Auditors either work within QA Departments of Pharmaceutical Companies and Contract Research Organizations (CROs), or may provide freelance Clinical Trial Auditing Service to multiple clients. In nut-shell a career as a Clinical Quality Auditor can be highly rewarding and challenging with numerous opportunities of career growth along the way.
Some responsibilities of Clinical Quality Auditors and of QA Professionals in general are:
- Writing, review and coordination in the development of Standard Operating Procedures (SOPs)
- Distribution, monitoring and control of standard operating procedures within the organization
- Conducting quality control review of clinical trial documents such as the study protocol and clinical trial report
- Conducting clinical trial site audits
- Conducting internal company audits to ensure compliance with applicable standards, guidelines and regulations
- Developing Quality Management Plan for the company
- Organizing and conducting training programs on quality within the organization
Competencies & Skills:
Various competencies and skills are required to become a Clinical Quality Auditor. Some of them are:
- Thorough understanding of the drug development process with extensive knowledge of ICH-GCP
- Extensive knowledge of clinical trial regulations such as those of US FDA, EMEA, DCGI etc
- Knowledge of GMP, GLP and GPP guidelines
- Eye for detail
- Good record keeping skills
- Assertive communication skills
- Knowledge of latest trends within the industry
- Problem solving skills
- Time management skills
- Bachelors or Masters degree in Pharmacy or Life Science is highly recommended
"I thoroughly enjoy the pharma perspective that your course gives to academicians like me."
Dr. Sarita Prabhakaran
Research Assistant and Pathologist
King Faisal Specialist Hospital
Riyadh, Saudi Arabia