Are you passionate about clinical research, quality and patient safety? Are you ready to grow your career in a role where your hands-on clinical trial experience can directly strengthen how studies are delivered?

We are hiring a motivated and organised self-starter for brand new role within our Quality team.

This opportunity may be ideal for a clinical research associate, nurse, study coordinator or clinical trial professional with strong GCP knowledge who is looking to broaden their experience and move into a quality-focused role within clinical research. Prior quality experience is valuable, but practical GCP clinical research experience is essential for success in this role.

As the Quality Assurance Associate, you will play a pivotal role in ensuring the integrity and effectiveness of our Quality Management System (QMS) and in promoting a quality by design culture.

Your responsibilities will encompass a wide range of quality assurance activities, including the implementation and maintenance of quality processes, compliance with GxP regulations, and continuous improvement initiatives.

Melbourne VIC and Sydney NSW(Hybrid) – The position may be performed remotely; however, the Quality Assurance Associate will be required to attend onsite (Sydney or Melbourne) to support quality assurance activities and other business-critical requirements as necessary.

Key Responsibilities:

Drive and maintain the procedures needed for an effective Quality Management System, covering all necessary GxP, Quality regulations and standards, including but not limited to, self-inspections, external audits and inspections, vendor qualifications, CAPA process and SOP compliance.





Implement and management of Quality System procedures and support the implementation and management of clinical research SOPs and/or work instructions, including adequate and timely GxP training assignments.

Manage deviations and change controls through identification, investigation, root cause determination, documentation, follow up and closure of actions including escalation if required.

Manage and implement document and records control according to procedures.

Lead continuous improvement efforts through the identification, follow-up, and closure of Corrective and Preventive Actions (CAPAs), including management of local CAPA process, and fulfilment of the role of CAPA coordinator.

Gather and report Key Quality Indicators in accordance with Corporate QA requirements.

Coordinate and prepare for internal (self-inspection), external (Sponsor) audits and Health Authorities / Notified Bodies Inspections.

Coordinate with relevant stakeholders on inspection/audit observation responses and ensure responses are within HA/NB timeline.

Lead and participate in internal and external audits and inspections as a qualified auditor and drive CAPA resolution (as applicable)

Ensure GxP vendors are properly qualified, monitored and processes are compliant with Quality requirements.

Collaborate with cross-functional teams to manage and drive vendor improvement in accordance with quality standards.

Issue quality notification and ensure appropriate vendor corrective actions are taken.





Maintain current knowledge of local and international regulatory and legislative requirements & trends to ensure that technical support on all quality related matters is provided.

Skills and experience required for the role:

Bachelor's degree in a Science, pharmacy, or a related field

3-5 years experience working in a similar role for a clinical research organisation

Qualified by training, education, and experience in clinical research

GCP certificate

Sound knowledge of standards relating to Quality Management Systems

Strong written and verbal communication skills

Strong knowledge of MS Office packages (e.g. Excel, Outlook, Word, PowerPoint

Exceptional attention to detail and strong organisational abilities

Excellent communication skills and the ability to work collaboratively in a fast-paced environment

Please note: quality experience gained solely in non-GCP industries is unlikely to be sufficient unless accompanied by robust, recent clinical research experience.

About us:

Canopy Clinical Research is a dedicated, multi-site, private Clinical Trials network on the East-coast of Australia. We conduct trials on a broad therapeutic range, from Phase 1 through to Phase 4. We excel in generalist studies with a large volunteer recruitment pool and have proven to be equally capable in delivering results for more specialist indications requiring patients.

Our Values:
At Canopy Clinical, we live by four core values:

Compassion: We respect and care for our participants, clients, and each other.

Connection: We build inclusive partnerships and a thriving community.

Commitment: We uphold the highest standard's and continuously improve.

Courage: We embrace bold steps and drive meaningful change

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📌 Quality Assurance Associate (New South Wales)
🏢 Canopy Clinical Research
📍 New South Wales