Clinical Trial Quality Officer

Posted 2 Days Ago
Be an Early Applicant
Parkville, MD, USA
In-Office
111K-120K Annually
Mid level
Professional Services
The Role
Lead clinical trial quality and compliance by conducting audits and inspections, developing governance processes and SOPs, advising investigators on GCP and regulatory requirements, identifying and remediating compliance risks, supporting audit/inspection preparation, and delivering training to ensure safe, ethical, high-quality research.
Summary Generated by Built In

Role type:Full Time; Continuing  
Department: Research, Innovation and Commercialisation (RIC) 
Salary: UOM 7 - $111,275 - $120,453 p.a. plus 17% super 

  • Specialist quality role shaping impactful clinical trials / collaborate across hospitals and research centres / join a values-driven university 

  • Drive best-practice clinical trial governance and apply now to support safe, compliant, high-quality research. 

  • Investing in you – 17% superannuation, benefits package including salary packaging, health and wellbeing programs, discounted services, and professional development opportunities. 
     

The University of Melbourne 
We take pride in our people, who all contribute to our mission to benefit society through the transformative impact of education and research. Discover more via our website. 

Your next career opportunity: 
In this role, you will strengthen the quality and compliance of clinical trials across the University. You will audit research governance, advise investigators and support training that ensures safe, ethical, regulatory-compliant studies. This is your chance to influence real-world health outcomes while building specialist clinical trial governance expertise. 

What you will deliver: 

  • Conduct audits and inspections of University-sponsored clinical trials against protocols, GCP, policies and regulatory requirements. 

  • Contribute to developing, implementing and refining clinical trial governance processes, standard operating procedures (SOPs), and related documentation. 

  • Identify compliance risks and root causes, recommending targeted training and process improvements with measurable impact. 

  • Provide GCP and regulatory advice to investigators and research staff across diverse clinical and academic sites. 

  • Support preparation for internal audits and external inspections and monitor implementation of corrective and preventive actions. 
     

You may be a great fit if you: 

  • Hold a tertiary qualification in a relevant science or healthcare discipline. 

  • Bring experience in clinical trial start-up, oversight and conduct within hospital, academic, pharmaceutical or Contract Research Organisation (CRO) environments. 

  • Demonstrate hands-on involvement in quality audits or inspections of clinical research activities or sites. 

  • Possess strong knowledge of GCP, NHMRC and TGA requirements, and national research ethics and governance frameworks. 

  • Have experience in quality or research management, including SOP development, review and continuous improvement. 

  • Excel at planning, organising and reporting, with meticulous attention to detail and clear stakeholder communication. 
     

What we offer you! 
We offer the opportunity to be part of a vibrant community and enjoy a comprehensive range of benefits to support your success and sense of fulfilment, including: 

  • Build future financial security with 17% superannuation 

  • Supportive flexible work arrangements underpinned by our commitment to inclusion and well-being 

  • Career development opportunities, including access to a range of tailored programs, such as Academic Women in Leadership, and learning platforms including LinkedIn Learning 

  • Progressive, considerate leave provisions to empower your work-life balance and well-being, including leading parental leave, gender affirmation leave and cultural leave 

  • Salary packaging and access to a range of discounted services including Bupa health insurance, and access to unique cultural and recreational benefits such as discounts for the Melbourne Theatre Company 

  • Health and well-being services including a leading Employee Assistance Program 
     

For more information check out our benefits page! 

Your new team: 
Research, Innovation and Commercialisation (RIC) sits within the Chancellery Research and Enterprise Portfolio, enabling the University’s research ambitions. Specialist teams partner with academics, hospitals, industry and government to secure funding, manage risk and translate discoveries. You will join the Research Ethics and Integrity function, working alongside passionate experts in governance, quality and compliance. Together, you will support safe, ethical clinical research within a collaborative culture valuing initiative, learning and service. 

Be Yourself 
The University of Melbourne is an Equal Opportunity Employer and a child-safe organisation. The diversity of our community enriches us all, and we are committed to creating an inclusive and fair workplace where everyone is valued, respected, and empowered to succeed. We welcome applicants from all backgrounds, identities, and experiences. Discover more about Diversity and Inclusion at UniMelb. 

We're committed to a barrier-free recruitment process and ongoing workplace support, providing adjustments throughout. We warmly encourage applications from people with disabilities. Learn more about how we support an accessible recruitment process. 

Aboriginal and Torres Strait Islander Applicants 
We aspire to be the University of choice for Indigenous Australians. Visit our Indigenous staff page to learn more about our investment and support for Aboriginal and Torres Strait Islander staff.  
    
Indigenous applicants are encouraged to connect with our Indigenous Employment & Development team at [email protected] 

Application essentials: 

  • Visit "apply with us" to learn more about the process, including tips and FAQs. 

  • You must have current valid work rights for Australia. Visa sponsorship is not available for this role.  

  • A Working with Children Check is required for all positions. If successful, we will guide you through the process and reimburse you.  

  • Please upload your resume and a cover letter outlining your interest and experience as part of the application process.  
     

Want to know more? 

  • For queries related to this specific position, contact Jia Wei Teo at [email protected] 

  • For questions related to our recruitment process email Alessandro Storani at [email protected]  

  • For recruitment adjustments contact Kim Groizard on +61 3 9035 3218 or at [email protected] (subject: 'Recruitment Adjustments').  
     

Apply today, and join a community that’s shaping the future. 

Applications close: Sunday 5 July 2026 - 11:55 PM; Melbourne time zone.  

Position Description:PD_JR-013727 Clinical Trial Quality Officer.pdf

PD_JR-013727 Clinical Trial Quality Officer.docx

Skills Required

  • Tertiary qualification in a relevant science or healthcare discipline
  • Experience in clinical trial start-up, oversight and conduct in hospital, academic, pharmaceutical or CRO settings
  • Hands-on involvement in quality audits or inspections of clinical research activities or sites
  • Strong knowledge of GCP, NHMRC and TGA requirements and national research ethics and governance frameworks
  • Experience in quality or research management, including SOP development, review and continuous improvement
  • Excellent planning, organising and reporting skills with meticulous attention to detail and clear stakeholder communication
  • Current valid work rights for Australia (visa sponsorship not available)
  • Working with Children Check (will be required and reimbursed if successful)
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The Company
0 Employees
Year Founded: 1853

What We Do

The University of Melbourne is a leading public research university that makes distinctive contributions to society in research, learning, teaching, and engagement.

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