Clinical Trials Quality Assurance Professional

4 days ago

Melbourne, Victoria, Australia beBeequality Full time $100,000 - $120,000

Quality Assurance Specialist Role

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A challenging opportunity has arisen to join a dynamic team as a Quality Assurance Specialist, working closely with the Clinical Trials management group. We are seeking a full-time employee, however part-time may be considered on negotiation.

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The clinical trials team has a reputation of excellence with expertise in managing clinical trials from First-in-human Phase I to Phase 3. We have over 200 clinical trials in progress, including Pharmaceutical Company sponsored, Collaborative Group and Investigator-initiated trials.

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About the Position

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The Quality Assurance Specialist will develop and maintain the department quality portfolio in accordance with organisational policies, National Standards, and clinical research ethical and regulatory requirements. The role is an integral member of the leadership group, modelling the core values through effective leadership, providing opportunities for learning and development, and fostering a positive culture of success.

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Main Responsibilities include:

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  • Develop initiatives aligned to NSQHSS, driving practice improvement at the local level.">
  • Review and development of 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.">
  • Facilitate audit and/or regulatory inspection process, supporting staff in audit preparation and report follow up processes.">
  • Collaborate with the Manager to improve efficiencies within clinical operations, developing SOPs and implementing risk evaluation and mitigation processes.">
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Qualifications/Skills/Experience required include:

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  • A registered Nurse with Nursing and Midwifery Board of Australia or Relevant Health Sciences Background.">
  • Extensive site experience in Clinical Trials management, direct clinical trial coordination.">
  • Excellent understanding of quality requirements for clinical trial coordination and trial related clinical care.">
  • Effective communication skills, problem solving in complex situations.">
  • Flexible, innovative team-oriented approach to service delivery.">
  • Leadership ability, clear understanding of the responsibilities of the Quality Assurance Specialist role.">
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The work environment within the Clinical Trials Centre is energetic, friendly and cohesive, with a strong teamwork ethic amongst all members.

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