Clinical Trials Operations Specialist

4 days ago


Melbourne, Victoria, Australia beBeeLeadership Full time $95,000 - $125,000
Job Opportunity: Clinical Trials Quality Lead

Cancer clinical trials have a reputation of excellence with expertise in managing clinical trials from first-in-human phase I to phase III. There are over 200 clinical trials in progress, including pharmaceutical company-sponsored, collaborative group, and investigator-initiated trials.

Key Responsibilities:
  • Develop and maintain the department's quality portfolio in accordance with Austin policies, national standards, and clinical research ethical and regulatory requirements.
  • Lead initiatives aligned to NSQHSS, particularly the National Clinical Trials Governance Framework, to drive practice improvement at the local level.
  • Review and develop orientation, training material, support, and competencies for new and existing trial coordinators.
  • Identify achievable and measurable quality assurance activities that align with organisational and research ethical standards.
  • Evaluate QA needs across the department and facilitate audit and/or regulatory inspection processes.
  • Assist in improving efficiencies within clinical operations by developing, reviewing, and overseeing SOPs and implementing risk evaluation and mitigation processes for clinical studies.
Qualifications and Skills:
  • A registered nurse with nursing and midwifery board registration or relevant health sciences background.
  • Extensive site experience in clinical trials management, including direct clinical trial coordination.
  • Demonstrated excellent understanding of quality requirements for clinical trial coordination and trial-related clinical care.
  • Ability to communicate effectively in written and verbal form, and problem-solve in complex situations.
  • Flexible, innovative team-oriented approach to service delivery.
  • Demonstrated leadership ability with clear understanding of the responsibilities of the quality lead role.


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