Research Quality and Compliance Specialist

2 weeks ago

Melbourne, Victoria, Australia beBeeCompliance Full time $125,000 - $145,000
Job Description

The Clinical Research Quality and Compliance Manager plays a pivotal role in ensuring the highest standards of quality and compliance in human research. This position is responsible for assisting in the development and improvement of quality frameworks, implementing quality assurance programs, and providing guidance on regulatory compliance.

This role requires strong project management skills, a deep understanding of human research methodologies, ethics, and governance, as well as expertise in clinical trials and regulatory frameworks.

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.
  • Providing recommendations and advice on research quality, compliance, and best practices, including study-specific issues.
  • Developing, implementing, and delivering training programs to support researchers in maintaining research quality and compliance.
Requirements
  • Postgraduate or graduate qualification with significant experience in clinical research.
  • 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.
  • Deep understanding of clinical research methodologies, ethics and governance, and regulatory frameworks (e.g. GCP, National Statement, Privacy Legislation).
Why Apply

You will have the opportunity to work in an exciting international research sector, exploring your potential and making a real difference. The Institute offers flexibility for work–life balance, generous salary packaging, an employee assistance program, social activities, learning and development opportunities, and modern offices and laboratories in a desirable location.

How to Apply

We invite applications from individuals who possess the required skills and qualifications, an appetite to learn, and a desire to join an organisation where they can make a positive impact.

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