31 Jul
|
QIMR Berghofer Medical Research Institute
|
Brisbane
31 Jul
QIMR Berghofer Medical Research Institute
Brisbane
Research Ethics and Governance Advisor (Human)
Join a leading medical research institute supporting human research
Use your clinical trial and regulatory expertise to support research
Attractive salary packaging & superannuation options
About QIMR Berghofer:
QIMR Berghofer is a world-leading translational medical research institute focused on improving health by developing new diagnostics, better treatments and prevention strategies, specifically in the areas of Cancer, Infection and Inflammation, Brain and Mental Health, and Population Health. Based in Herston, Brisbane and working in close collaboration with clinicians and other research institutes, QIMR Berghofer is home to more than 600 scientists, students and non-research staff.
About Research Ethics and Governance Team:
As part of the Research Governance and Funding Department, the Research Ethics and Governance team manages the interface between ethics committees, researchers and state, federal and international regulatory bodies, ensuring QIMR Berghofer's ethical systems and processes are effective and support researchers.
Role Purpose / Responsibilities:
Reporting to the Senior Manager, Research Ethics and Governance, you will play a key role in supporting the ethical and compliant conduct of human research across the Institute, with a particular focus on clinical trials and other regulated research activities.
This position is ideally suited to a clinical research skilled with experience in clinical trial monitoring, site management, quality systems or regulatory compliance. You will work closely with researchers, study coordinators, sponsors and external stakeholders to support study start-up, ethics and regulatory submissions, monitoring activities, quality management systems and ongoing compliance throughout the research lifecycle.
Key responsibilities include:
Coordinating ethics, governance and regulatory approvals for human research and clinical trials
Responsible for clinical trial start-up,
site activation and ongoing ethics and governance study management activities
Conducting monitoring, quality assurance and compliance reviews across clinical trials and human research projects
Reviewing study documentation, regulatory files, protocol deviations and corrective and preventative actions (CAPAs)
Managing and enhancing the Clinical Trial Quality Management System
Providing expert advice to researchers regarding ethics, governance, Good Clinical Practice (ICH-GCP) and regulatory requirements
Supporting sponsor audits, monitoring visits and regulatory inspections
Delivering education, training and guidance to researchers on research ethics and compliance requirements
Contributing to continuous quality improvement initiatives that strengthen research governance and participant safety
This is a unique opportunity to leverage your clinical research expertise while broadening your experience across research ethics, governance and compliance in a leading medical research environment.
About you:
If you are an experience clinical research professional with a strong understanding of clinical trial operations, regulatory requirements and quality management principles. You are confident working with a diverse range of stakeholders and enjoy helping researchers navigate complex ethical and compliance requirements.
To be successful in this role, you will have:
Tertiary qualifications in science, nursing, allied health or a related discipline
Experience working in a pharmaceutical company, contract research organisation (CRO),
research institute or healthcare setting.
Experience as a Clinical Research Associate (CRA), Clinical Trial Coordinator, Clinical Trial Manager, or in a similar clinical research role
Practical experience in clinical trial monitoring, site management, study start-up, regulatory compliance and/or quality oversight activities
Strong knowledge and application of International Council for Harmonisation – Good Clinical Practice (ICH-GCP)
Experience working with sponsors, CROs, investigators and research sites
Experience supporting audits, inspections, monitoring activities and quality improvement initiatives
Excellent organisational, analytical and problem-solving skills
Outstanding communication and stakeholder engagement capabilities
The ability to manage multiple priorities while maintaining a high level of accuracy and attention to detail.
Experience in research ethics, research governance or regulatory affairs will be highly regarded although candidates with strong clinical trial monitoring and compliance experience who are keen to develop broader governance expertise are encouraged to apply.
Remuneration:
Salary range is $109,791 to $121,898 p.a. plus super and generous salary packaging. This is a full time, permanent appointment.
Applicants must be an Australian Citizen, Permanent Resident or hold a valid work permit or visa. Work eligibility will be checked as part of the recruitment process.
Why Join Us?
Support research that improves lives and advances healthcare outcomes
Salary packaging perks (up to $15,900 of your annual salary tax free)
Salary package up to $2,650 of your pre-tax income for entertainment expenses
Employee Assistance Program
Fitness Passport Gym Membership
Generous leave provisions including an annual Wellbeing Day
Professional Development Opportunities
Commitment to equity, diversity, and inclusion
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📌 Research Ethics And Governance Advisor (Human) (Brisbane)
🏢 QIMR Berghofer Medical Research Institute
📍 Brisbane