The Research Governance Officer (or Compliance Officer) provides support and advice to the relevant Chief Executive Officer (CEO) or their delegate, Director of Research, Human Research Ethics Committee (HREC), site-specific assessment office, trial investigators and their teams, as well as trial sponsors. This is achieved in accordance with the NHMRC: National Statement on Ethical Conduct in Human Research, national regulation and legislation and jurisdictional policies.
The Research Governance Officer (or similar), provides oversight of the implementation of the National Clinical Trials Governance Framework. The role promotes awareness of the organisation-wide approach to providing clinical trial services and ensure services and administrative systems are in place to review, monitor and evaluate clinical trials being conducted within a health service organisation.
The Research Governance Officer or their delegate, team or office may also be responsible for:
- Ensuring awareness of the importance of the NHMRC: National Statement on Ethical Conduct in Human Research and the NHMRC: Australian Code for the Responsible Conduct of Research across the organisation.
- Monitoring relevant regulatory and policy developments to ensure changes are incorporated into local policies and procedures in a timely manner.
- Leading the development and implementation of systems and implementation of best practice policy, procedures, and standardised systems within the relevant health system to improve the conduct and governance of clinical trials in collaboration with the governing body, managers, clinicians, patients, consumers and trial sponsors.
- Providing information, education and advice on research governance matters to stakeholders involved in the conduct and management of clinical trials in accordance with national and local policies, guidelines and other reference material adopted by the jurisdiction.
- Monitoring clinical trial activity within the relevant health service organisation or trial site, and facilitating or coordinating the preparation of the annual clinical trial report.
- Undertaking risk management assessments regarding clinical trial services and procedures to promote responsible clinical trial conduct.
- Implementing systems for the management of complaints about clinical trials including clinical trial misconduct and fraud and manage clinical trial complaints, misconduct or conflicts of interest related to the conduct of authorised clinical trial projects.
- Conducting or co-ordinating audits of clinical trial projects, where required.
- Preparing reports to regulatory bodies as required.
- Maintaining records, including databases and filing systems.
- Determining compliance with relevant legislative and policies.
