Quality Assurance Specialist

2 days ago

Melbourne, Victoria, Australia beBeeCompliance Full time $96,000 - $124,000

Clinical Research Quality and Compliance Manager

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This role is responsible for assisting in the development and improvement of research policies and guidelines. It also involves implementing a quality assurance program to ensure the highest standards are maintained.

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  • 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.
  • Engaging with researchers to promote adherence to policies and regulations, and encourage best practices in human research.
  • Participating in Institute committees and consultations related to research quality and compliance.
  • Supporting the maintenance and enhancement of systems and resources related to Human Research Governance, including document management, data capture platforms, and the Institute's intranet content.
  • Working effectively with researchers, professional services, institute management, and external agencies to support human research activities.
  • Providing advice and support to the Human Research Governance Officer.
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Qualifications\
  • Postgraduate or graduate qualification with significant experience in clinical research. Experience in the commercial sector is 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.
  • Deep understanding of clinical research methodologies, ethics and governance, and regulatory frameworks (e.g. GCP, National Statement, Privacy Legislation).
  • Strong interpersonal and communication skills, with the ability to work effectively in teams and engage diverse internal and external stakeholders.
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Benefits\

We offer a competitive salary commensurate with qualifications and experience, flexibility for work–life balance, generous salary packaging, an employee assistance program, social activities, learning and development opportunities. We also offer modern offices and laboratories in the Alfred Research Alliance precinct with an onsite gym, located opposite Fawkner Park; and walking distance to Chapel Street and St Kilda Road.

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How to Apply\

To be eligible to apply for this position, you must have appropriate Australian working rights.

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