Clinical Research Governance Specialist

3 days ago

Melbourne, Victoria, Australia beBeeCompliance Full time $100,000 - $125,000
Job Overview

The Clinical Research Quality and Compliance Manager oversees the development and enhancement of quality frameworks for human research initiatives. This role necessitates exceptional project management skills and a profound understanding of clinical trials and regulatory frameworks.


Key Responsibilities
  • Supporting and improving 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.

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.

What We Offer

A flexible work environment that supports work–life balance, generous salary packaging, an employee assistance program, social activities, learning and development opportunities, and modern offices and laboratories in a prominent research precinct.

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