Position Summary

The Clinical 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 experience in clinical trials, and ideally, have experience in investigator-initiated trials and other types of human research. 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.

Key Responsibilities

Clinical Trials


• Manage BI’s Sponsor responsibilities for clinical trials, such as:
o Notify regulatory authorities;
o Prepare trial documents for BI sponsored clinical trials;
o Assist researchers preparing documentation for BI sponsored clinical trials;
o Maintain sponsor files;
o Undertake 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 comply 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 follow the most up-to-date legislation and guidelines.


Support for Quality Management


• Provide assistance, as required, to support BI’s Quality Management processes.

Key Selection Criteria

Essential


• Experience in clinical trials.
• Experience in dealing with Human Research Ethics Committees.
• 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.
• Strong organisational skills with an ability to prioritise work independently.


Desired


• Knowledge and experience of medical device standards, such as ISO 14155, ISO 14971, and TGA regulation of medical devices
• Experience in governance of other types of human research
• Understanding and experience negotiating clinical trial research agreements
• Experience in developing governance processes for clinical trials and human research

Knowledge

The incumbent is expected to understand the requirements of GCP, ethics committees, and undertaking a clinical trial. They will understand the legislation and guidelines relating to human research in Australia to ensure the Bionics Institute complies with relevant regulatory requirements. They will understand the structure and processes for establishing and maintaining a compliant framework for clinical trials and human research.

Level of Supervision, Independence

The incumbent is expected to carry out a range of tasks that require a high level of planning with excellent attention to detail. They are expected to exhibit initiative and flexibility in anticipating and responding to needs. The incumbent will have the ability to work autonomously with a collaborative and consultative style.

Problem Solving, Judgement

The incumbent will have a hands-on and pragmatic approach to identifying and proposing solutions. They will be able to identify and develop processes and procedures that are compliant with the relevant regulatory requirements. The incumbent will be able to develop and maintain resource information for researchers with the ability to implement training across the clinical trials and human research teams.

Interpersonal and Organisational Skills

The incumbent will require highly developed interpersonal and communication skills with an excellent command over written and verbal communication. They will need to be able to develop a quick rapport with a wide range of people, to communicate clearly and be able to have empathy with others, specifically being able to understand the researcher’s perspective. They must be able to be directive, as required, to ensure organisational compliance with policies, legislation and guidelines relating to human research in Australia. The incumbent must have strong organisational skills with an ability to prioritise work independently. They will be driven to continuously learn new skills and take on additional activities.

The Clinical Research Governance Manager position is a 3-year contract.

Requirements

A police check is required. If you believe you meet the requirements for this position, please submit your application via SEEK. Please include a CV and a brief cover letter addressing the selection criteria.

Applications for the Clinical Research Governance Manager will remain open until the position has been filled. For further information about the Clinical Research Governance Manager position, please contact the Head of Grants and Research Governance, Janine Clarey, by email: [email protected]

Bionics Institute is an equal opportunity employer and female applicants are encouraged to apply. The Institute is committed to maintain a smoke free workplace and a workplace that is free from sexual harassment. The Bionics Institute’s workplace embraces the Occupational Health and Safety Standards.

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