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24

May

Hrec Non-drug Trials Officer

Austin Health - Melbourne, VIC

Health, Medical & Pharmaceutical
Source: uWorkin

JOB DESCRIPTION

Full Job Description
Job Description

Location: Melbourne | Northern Metropolitan

Job type: Not provided

Organisation: Austin Health

Salary: Salary not specified

Occupation: Health and Allied Health, Research

Reference: 37639

Austin Health is the major provider of tertiary health services, health professional education and research across 3 campuses in the northeast of Melbourne and state-wide. Austin Health is world-renowned for its research and specialist work in cancer, liver transplantation, spinal cord injuries, neurology, endocrinology, mental health and rehabilitation.

An exciting opportunity currently exists for an enthusiastic and highly experienced Research Ethics Officer - Non-Drug Trials to join our Office for Research at Austin Health.

About the Office for Research

The Office for Research is responsible for handling the approval of all research projects undertaken at Austin Health through the relevant committees and processes. It ensures that research is conducted within the approved regulatory frameworks and codes. Over 800 innovative researchers at Austin Health’s research precinct are turning science into better health outcomes.

Excellence in research is achieved within a framework that ensures that research is conducted responsibly, safely and is both scientifically and ethically sound. The research encompasses a broad range of diseases that are significant in our community, including diabetes, heart disease, cancer and epilepsy. The results of our research are showcased each year during a week of presentations and seminars called ResearchFest http://www.austin.org.au/ResearchFest/

The precinct includes Hospital and University of Melbourne Departments and the following Independent Medical Research Institutes: Florey Institute of Neuroscience and Mental Health, Olivia Newton-John Cancer Research Institute, Institute for Breathing and Sleep, Parent-Infant Research Institute and the Spinal Research Institute.

Purpose and Accountabilities

Role Specific:
To complete an initial administrative review of submissions, create meeting agenda, minutes, correspondence of issues and outcomes arising from the review and approval of new applications

To provide guidance, support and feedback to researchers seeking ethics and governance approval for clinical trials and research projects involving humans

To record and review the governance package, including the review of insurance, indemnity and legal documents (eg. Agreements, MTAs, MOUs) and where required, to seek legal counsel in relation to these documents

To review and maintain CTNs and indemnity forms to ensure appropriate processing. To also ensure that a copy of the TGA Acknowledgement of CTNs is received by the Principal Investigator before a study commences (if relevant)

To assist in the engagement of internal and external expertise as required for review of applications

To liaise with the Austin Health Radiation Safety Officer and ensure compliance with radiation safety and licensing requirements, including ensuring the inclusion of new projects to the radiation license where required

To review the Annual and Final Reports submitted by Investigators

To review the adverse events, serious and non-serious breaches

To liaise with the Chair of the HREC and organise ‘out of session reviews’ where required

To provide support and training to members of the Office for Research as well as external stakeholders and online training guidelines on the use of the ERM research platform and other areas of the research process.

To review all post-approval correspondence relating to amendments and other post-approval actions for all accepting submissions.

In addition:
To assist and direct the database administrator to ensure effective and timely updates of data into ERM and ReDA.

Provide on-site training for both researchers and OFR staff and online training guidelines on the use of the ERM research platform

To assist as needed with accreditation activities.

To assist with updating and creating material and templates for the internet and intranet as required.

To participate in the development, implementation and evaluation of existing and future initiatives to improve the services offered by the Office for Research including updates to operating procedures, templates, attending relevant training, and professional development courses.

Other ad hoc duties as required.

Comply with Austin Health policies & procedures, as amended from time to time, which can be located on the intranet (The Pulse): https://austinhealth.sharepoint.com/sites/OPPIC

Report incidents or near misses that have or could have impact on safety - participate in identification and prevention of risks

Comply with the Code of Conduct

Selection Criteria

Essential Knowledge and skills:
A commitment to Austin Health values: Our actions show we care, we bring our best, together we achieve and we shape the future.

Qualifications in a relevant discipline (BSc or equivalent with a working knowledge of medical terminology /scientific language)

A sound understanding of the legislation, codes and guidelines relevant to clinical and research ethics, and in particular the NHMRC National Statement on Ethical Conduct in Human Research, relevant privacy acts and guidelines, The Australian Code for the Responsible Conduct of Research, National Mutual Acceptance (NMA) and the Therapeutic Goods Act as it relates to use of medications and devices in human research.

Demonstrated excellent verbal and written communication skills

Enthusiasm, willingness to learn and contribute to the team

Experience with data management including data extraction and loading

Proficient in the use of Microsoft Office, database and spreadsheet software applications

Discretion and confidentiality with regard to treatment of information in reports, discussions in meetings

Familiarity with the ERM database.

Broad understanding of the health and medical research environment in Victoria and Australia

Previous experience within a research ethics office handling ethics submissions or with research including submissions to and communication with an ethics committee

Demonstrated understanding of clinical trial agreements for research projects

Excellent time management and organizational skills and attention to detail and the capacity to operate autonomously and be self-motivated

Responsible for maintaining current knowledge of all relevant issues pertaining to research ethics and governance

Desirable but not essential for Performance in the Position

Demonstrated successful history of coordinating research / and or ethics activity in a hospital or research environment

Melbourne, VIC

Health, Medical & Pharmaceutical




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