- Competitive salary offered commensurate with the successful candidate’s qualifications, skills and experience.
- Full-time position (part-time 0.8 FTE considered).
- 2-year fixed-term contract.
About the Baker Institute
Imagine being part of a healthcare transformation where each breakthrough brings us closer to cures and life-changing discoveries. At the Baker Heart and Diabetes Institute, we are not just conducting research, we are changing lives.
By working towards cures for heart disease and diabetes, we are tackling Australia’s biggest killers head on. Our relentless pursuit to reverse the life-threatening impacts of associated conditions reflects our commitment to combat these fast-growing diseases.
We are at the heart of some of the world’s greatest scientific breakthroughs. Through our research, we are empowering individuals with the knowledge and tools to adopt healthier lifestyles, ensuring they live longer and more fulfilling lives.
Join us at the Baker Heart and Diabetes Institute. Every step we take brings us closer to a healthier future. By working together, we can make a real difference in the lives of those affected by cardiovascular disease and diabetes.
The opportunity
The Clinical Research Quality and Compliance Manager reports to the Head of Research Strategy and Operations, and is responsible for assisting in the policy/guideline development and improvements to the quality framework for human research and implementing an ongoing quality assurance program at the Institute. This role requires strong project management skills and a deep understanding of how human research works — especially clinical trials and current regulatory frameworks governing the conduct and oversight of human research.
If you're someone who knows the ins and outs of research ethics, governance, and quality systems, this is your kind of challenge.
How this role makes a difference
The Clinical Research Quality and Compliance Manager will play a pivotal role in safeguarding the integrity, safety, and ethical standards of human research at the Institute.
Through this key role, you can contribute to our vision to help people to live healthier for longer, and to stop heart disease and diabetes in their tracks.
How you’ll make an impact
As of our new Clinical Research Quality and Compliance Manager, you will be responsible for:
- Supporting and enhancing research monitoring and quality assurance through risk-based frameworks, internal QA programs, audits, and corrective action tracking.
- Leading regulatory compliance efforts, including coordination of GCP inspections, TGA submissions, and adherence to evolving legislation and guidelines.
- Advising on and maintaining research governance policies and procedures, ensuring alignment with best practices and regulatory standards.
- Providing recommendations and advice on research quality, compliance, and best practices, including study-specific issues.
- Developing, implementing, and delivering training programs to support researchers in maintaining research quality and compliance.
- Engaging with researchers to promote adherence to policies and regulations, and encourage best practices in human research.
- Participating in Institute committees and consultations related to research quality and compliance.
- Supporting the maintenance and enhancement of systems and resources related to Human Research Governance, including document management, data capture platforms, and the Institute’s intranet content.
- Working effectively with researchers, professional services, institute management, and external agencies to support human research activities.
- Providing advice and support to the Human Research Governance Officer.
What will you bring?
You will have:
- Postgraduate or graduate qualification with significant experience in clinical research. Experience in the commercial sector is desirable.
- Proven ability in people, project, and stakeholder management, with a strong track record in handling multiple priorities and driving organisational improvement.
- Extensive experience with quality management systems, audits, and research compliance, including policy development, training, and quality assurance monitoring.
- Deep understanding of clinical research methodologies, ethics and governance, and regulatory frameworks (e.g. GCP, National Statement, Privacy Legislation).
- Strong interpersonal and communication skills, with the ability to work effectively in teams and engage diverse internal and external stakeholders.
So, why join us?
You can enjoy a challenging career in the exciting international research sector where you can explore your potential and make a real difference.
The Baker Institute offers flexibility for work–life balance, generous salary packaging, an employee assistance program, social activities, learning and development opportunities. We also offer modern offices and laboratories in the Alfred Research Alliance precinct with an onsite gym, located opposite beautiful Fawkner Park; and walking distance to Chapel Street and St Kilda Road.
Remuneration will be commensurate with the successful candidate’s qualifications and experience.
How to apply
We’re reviewing applications as they are received, so if this sounds like the position for you, you have the skills and knowledge we’re looking for, an appetite to learn, and want to join an organisation where you can make a positive difference please apply without delay. Please refer to the position description for further information.
Applications should include a current resume (CV), a 2-page research statement and details of 3 professional referees quoting reference (TM01).
To be eligible to apply for this position, you must have appropriate Australian working rights.
Please note offers of employment are subject to satisfactory background checks and the successful candidate will be required to undertake a police check prior to commencement in the position.
Contact details
HR team
E: recruitment@baker.edu.au