Clinical Trial and Human Research Governance Manager Part-time opportunity available at the Bionics Institute. About the Bionics Institute The Bionics Institute is a world leader in the development of medical devices for the treatment of otherwise intractable conditions. The Bionics Institute is in an exciting phase, developing therapeutic technology to assist those with Parkinson’s disease, diabetes, arthritis, blindness, inflammatory bowel disease and hearing loss. We are also working on the development of unique methods for the improved diagnosis of epilepsy, movement disorders and deafness. About the role Working within a small dynamic team, the Clinical Trial and Human Research Governance Manager will ensure that all human research activities at the Bionics Institute comply with relevant regulatory requirements. This role requires a pro-active approach to improve and build upon existing governance processes at the Bionics Institute. The incumbent will have extensive experience in human research governance, including clinical trials. The incumbent is expected to take a hands-on approach to improve the Institute’s human research governance processes, particularly those related to clinical trials. This role has an important part to play in ensuring that research and development at the Bionics Institute ends up benefitting patients. The position reports to the Head of Grants and Research Governance. This position will work mainly from the office and is located at 384-388 Albert Street, East Melbourne. Key responsibilities Include but are not limited to: Clinical Trials Oversee and manage BI’s sponsor responsibilities for clinical trials, such as: Notify regulatory authorities; Prepare trial documents for BI sponsored clinical trials; Assist researchers preparing documentation for BI sponsored clinical trials; Maintain sponsor files; Undertake and oversee clinical trial initiation, monitoring and close-out activities. Identify and implement processes to ensure that BI’s clinical trials are fully compliant with the relevant regulatory requirements. Provide researchers with hands-on assistance in navigating ethics and governance application processes. Establish and maintain information resources and training to aid researchers undertaking clinical trials. Ensure that BI’s clinical trial activities are in compliance with the most up-to‑date legislation and guidelines. Human Research Governance Maintain and improve BI’s Human Research Policies and Processes, ensuring they are consistent with external guidelines, policies and legislation. Identify and implement processes to improve the internal review of human research at BI, using a risk management approach. Provide researchers with hands-on assistance with applications to Human Research Ethics Committees. Maintain central records for BI’s research approved by Human Research Ethics Committees. Monitor BI’s Human Research, in accordance with the National Statement on the Ethical Conduct of Human Research. Establish and maintain information resources and training to aid in educating researchers on governance requirements and responsibilities relevant to Human Research. Act as the contact for receipt of complaints from research participants. Ensure that BI’s human research activities are in compliance with the most up-to‑date legislation and guidelines. Key Selection Criteria Knowledge, skills and experience In-depth knowledge of the legislation and guidelines relating to human research in Australia; for example, The National Statement on Ethical Conduct in Human Research, ICH GCP, Therapeutic Goods Act, Australian Code for the Responsible Conduct of Research. Knowledge and experience of medical device standards, such as ISO 14155, ISO 14971, and TGA regulation of medical devices will be highly regarded (but not essential). Experience in clinical trials, and governance of human research, including dealing with Human Research Ethics Committees. Understanding and experience negotiating clinical trial research agreements will be highly regarded. Experience in developing governance processes for clinical trials and human research will be highly regarded. Strong organisational skills with an ability to prioritise work independently. Personal qualities Able to work independently, with a collaborative and consultative style. Hands-on and willing to do the work, rather than delegating to others. Able to propose pragmatic solutions, in a complex regulatory environment Driven by a desire to continually improve, rather than aiming at perfection Effective at communicating and influencing others Able to be directive, as required, in order to ensure organisational compliance with policies, legislation and guidelines relating to human research in Australia Able to have empathy with others, specifically being able to understand the researcher’s perspectives Previous experience in the medical research, health, university or NFP sector is advantageous. A flexible work arrangement will be considered (up to 60% EFT negotiable). The position is available immediately and we will commence interviewing as suitable applications come in. If you are interested in this role, please submit your application as soon as possible. Download the full job description. For further information, please contact: Janine Clarey, Head of Grants and Research Governance, on (03) 9667 7573 or [email protected] How to applySubmit your application by clicking ‘Apply for Job’ via SEEK. Please include a brief cover letter that addresses the selection criteria. Applications close on Friday 9 July.