About the Role/ Opportunity

The Research Governance Officer manages and ensures the efficient and timely processing of applications from receipt through to final authorisation and maintains accurate records of each. The incumbent must be well-versed in the practical application of the Australian Code for the Responsible Conduct of Research, Good Clinical Practice Research Guidelines, Australian and Victorian Privacy Legislation, Therapeutic Goods Act and the National Clinical Trials Governance Framework. The key functions of the role include:

- Provide overall management, including validation, review and authorisation of applications submitted to Monash Health for Site Specific Authorisation.
- Co-ordinate amongst Research Support Services and manage the application process which includes management of the Monash Health database and Ethical Research Manager (ERM), in accordance with the reporting requirements of the NHMRC.
- Provide advice to researchers and the Research Support Services team on the implications of proposals, application procedures and regulatory requirements.
- Manage the annual report review process, including problem solving for the newly implemented online annual reporting process and implementing ICH GCP compliance training.
- Review of standard research agreements, including maintaining an up-to-date tracker.
- Provide back up support to the Research Governance Manager of non-standard research agreements.
- Designing and delivering targeted training programs with respect to research governance matters,



and modify as required with updates to guidelines, policies and procedures and legislation.
- Undertake current project work, including assisting the Head, Research Operations with the preparation of accreditation and reporting documentation to ensure the achievement of required standards.
- Represent Monash Health in external forums such as Safer Care Victoria initiatives.
- Provide backup cover where the Research Governance Manager is engaged in other duties and act as a delegated authority on his behalf when on leave.

About You

Qualification/ technical skills/ knowledge/ experience:

- Completion of a degree (preferably in a health sciences field) with subsequent relevant experience or extensive experience, leading to the development of specialist expertise in administrative fields or a combination of relevant knowledge, training or experience.
- 3-5 years work experience in Research Ethics & Governance.
- Experience in the health or research sector.
- Experience liaising with senior clinical staff.
- Proficient in the use of Clinical Trial Management systems.
- Proficient in the use of database and spreadsheet software applications.
- Track record of developing high quality reports for Executive level consideration.
- Proficiency in providing education and training support to a range of stakeholders.
- High level time management skills to manage competing deadlines and complete work in accurate and organised manner.
- High level communication skills including in person, telephone and email communication.

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📌 Research Governance Officer (Melbourne)
🏢 Monash Health
📍 Melbourne