Ethics Research Assistant
Clayton, VIC, AU, 3168
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Join our team as an Ethics Research Assistant on a part time (24 hours/ 3 days), ongoing term to work at Haematology Research based at Clayton.
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Assist in preparing and submitting the regulatory documentation to the Human Research Ethics Committee (HREC) and Research Governance (RGO) for clinical trials of the Haematology Research Unit.
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Draft and format study documents — e.g., Participant Information and Consent Forms (PICFs), investigator CVs, and study summaries, per ethics requirements.
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Coordinate and respond to HREC/RGO queries or requests for clarification, and track submission timelines.
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Support protocol amendments, site authorizations, annual reports, safety reports, and compliance documentation.
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Maintain accurate records and version control of all ethics and regulatory correspondence.
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Ensure study documents align with current regulations, policies, and templates.
About us
Monash Health Haematology has a large Clinical Trials Unit and utilises the purpose-built state of the art Clinical Trials Unit at the Monash Health Translation Precinct to implement new and exciting clinical trial opportunities for our patients. Our Clinical Trials Unit currently runs ~120 clinical trials in all aspects of haematology, focussing on malignant as well as haemostasis/thrombosis trials, and offers patient-centred care to patients with complex needs. This is a dynamic and fast-paced team, working in an ever-evolving developmental areas such as targeted therapy, immunotherapy, and chemotherapy.
About you
The Ethics Research Assistant will work in conjunction with other members of the Haematology Research Unit. A strong collaboration between the unit, the trial sponsors, and Monash Health is required in planning, coordinating and implementing trials to ensure the best possible care for trial patients. The position is to effectively and efficiently manage the regulatory documentation and communication with the Human Research Ethics Committee (HREC) & RGO for clinical trials of the Haematology Research Unit by following Good Clinical Practices as set out by the International Conference on Harmonisation.
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Bachelor’s degree in science, health, or related discipline.
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Sound knowledge of human research ethics, research governance, ICH-GCP, NHMRC and clinical trial regulatory frameworks.
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Experience preparing or supporting HREC/ RGO in a clinical trial setting.
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Excellent attention to detail, organisation, and document management skills.
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Strong written communication and ability to work with multidisciplinary research teams.
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Strong organisational and time-management skills to meet multiple deadlines.
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Ability to work both independently and collaboratively within a research team environment.
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Proficiency in Microsoft Office and familiarity with online ethics submission portals (e.g., SSA, VSM).
For a confidential discussion and to explore the opportunity further, please email Purwani (haemResAdmin@monashhealth.org)
Position Description can be found here
We recognise the value of equal employment opportunity. We are committed to patient safety, promoting fairness, equity and diversity in the workplace and to Child Safe Standards. At Monash Health we are relentless in our pursuit of excellence and work to our six guiding principles and our five ICare values.
How to Apply
Applications are accepted via the Monash Health online EHub system. For information including how to apply and probity check requirements, please click here for the ‘Application Guide’
Applications will be screened upon receipt and selection activity may commence prior to the closing date.
Applications close: 24 November, 2025