MAIN PURPOSE OF ROLE
• Individual contributor representing the most common entry point for this career stream.
• Works under direct supervision.
MAIN RESPONSIBILITIES
• Primary responsibility is ensuring implementation of quality plan at every stage of the Clinical Trial process/operations.
• Implement Quality Assurance regulations.
• Write and revise standard operating procedures.
• Support and facilitate audits and regulatory inspections.
• Support Quality Assurance Manager in supervision of all quality control aspects of the process (laboratories studies, clinical research, testing, operations).
• Ensure that standards are met and report potential issues either with quality or reliability of testing procedures.
• Lead implementation of new regulations.
• May support quality training.
QUALIFICATIONS
High School Diploma / GED