Clinical Research Quality Assurance Specialist
7 days ago
The role of Clinical Research Quality and Compliance Manager involves assisting in the development and improvement of quality frameworks for human research and implementing ongoing quality assurance programs.
Key Responsibilities- Supporting and enhancing research monitoring and quality assurance through risk-based frameworks, internal QA programs, audits, and corrective action tracking.
- Leading regulatory compliance efforts, including coordination of GCP inspections, TGA submissions, and adherence to evolving legislation and guidelines.
- Advising on and maintaining research governance policies and procedures, ensuring alignment with best practices and regulatory standards.
- Developing, implementing, and delivering training programs to support researchers in maintaining research quality and compliance.
- A postgraduate or graduate qualification with significant experience in clinical research is required. Experience in the commercial sector is highly desirable.
- Proven ability in people, project, and stakeholder management, with a strong track record in handling multiple priorities and driving organisational improvement.
- Extensive experience with quality management systems, audits, and research compliance, including policy development, training, and quality assurance monitoring.
- A deep understanding of clinical research methodologies, ethics and governance, and regulatory frameworks (e.g. GCP, National Statement, Privacy Legislation) is essential.
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