Ethics & Governance Specialist

1 week ago

Melbourne, Victoria, Australia Monash Health Full time $104,000 - $130,878 per year

About the Role - Ongoing (0.5 EFT)

As a member of the Monash Kids Research Unit team at Monash Health, the Ethics & Governance Specialist will have responsibility for the coordination of the submission of research studies undertaken in the Monash Kids Research department to the relevant HREC Department. Will be responsible to coordinate all pre and post approval submissions of clinical trials to ensure their effective and timely approval and implementation, act as a guide to clinical trial assistants and to clinical staff as to the regulatory submission of all research documents and assist with the study budget negotiations and the establishment of clinical trial agreements. The Ethics & Governance Specialist will report to the team lead for day to day workload and subsequently to the Manager who will provide professional management. Formal appraisal of performance will be conducted by the Manager on a regular basis. Workload may be variable dependent on the number and status of research studies within the department.

Key Result Areas:

  • Ensure ethics and governance submissions are performed according to agreed timelines
  • Work with other staff to ensure they are aware of the ethics and governance requirements and provide training in these areas
  • Oversee the submission of trial amendments
  • Develop expertise in the ethics review management system (ERM)
  • Ensure management, investigators and teams are kept informed of the progress of trial submissions
  • Assist with study budget negotiations and the establishment of clinical trial agreements
  • Maintain professional relationships with both internal and external contacts
  • Maintain the confidentiality required by sponsors

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