About the Prospect
We are partnering with a growing, specialist clinical research organisation that is entering an exciting phase of expansion and operational maturity.
As part of this growth, the business is seeking a
Quality & Training Associate
to play a key role in maintaining and strengthening quality systems, compliance standards, and workforce capability across the organisation.
This is an opportunity to join a highly collaborative environment where quality is viewed as a business enabler rather than an administrative function.
The successful candidate will work closely with operational leaders, study teams, and clients to ensure clinical research activities remain inspection-ready, compliant, and aligned with industry best practice.
For someone looking to build a long-term career within clinical quality, compliance, and operations, this role offers genuine visibility, responsibility, and future growth potential.
The Role
You will act as a key resource across both Quality and Training, helping ensure clinical programs are delivered in accordance with ICH-GCP, sponsor expectations, and internal quality standards.
Responsibilities will include:
Quality & Compliance
Support the ongoing management and improvement of the Quality Management System (QMS).
Maintain quality documentation, including SOPs, work instructions, CAPAs, deviations, change controls, and training records.
Support internal audits, external audits, sponsor assessments, and inspection readiness activities.
Assist with investigations, root cause analyses, corrective actions, and continuous improvement initiatives.
Ensure quality documentation remains accurate, current, and compliant.
Participate in risk assessments and process improvement projects.




Partner with operational teams to promote a strong quality culture across the organisation.
Training & Development
Coordinate and maintain organisation-wide training and competency programs.
Manage training records and compliance tracking.
Support onboarding and induction activities.
Coordinate GCP, SOP, systems, and process-related training.
Ensure all training documentation remains audit-ready and inspection-ready.
Support the development of learning resources and training materials.
Stakeholder Engagement
Act as a trusted point of contact for quality and compliance queries.
Work closely with cross-functional clinical research teams.
Support client-facing quality activities as required.
Build strong relationships across operational and leadership teams.
About You
You will likely bring:
Experience working within a CRO, clinical research, or clinical trials environment.
Strong understanding of ICH-GCP requirements.
Hands-on experience supporting clinical quality and compliance activities.
Exposure to Quality Management Systems (QMS).
Experience managing SOPs, CAPAs, deviations, document control, or audit activities.
Excellent organisation and attention to detail.
Strong communication and stakeholder management skills.
A proactive approach and the ability to work independently.
Why Consider This Opportunity?
Join a growing and highly regarded clinical research organisation.
Broad exposure across quality, compliance, training, and operations.
Work directly with experienced industry leaders.
Genuine opportunity to influence processes and contribute to organisational growth.
Strong career development potential as the business continues to expand.
Cooperative culture where individuals are encouraged to take ownership and make a visible impact.
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📌 Quality & Training Associate (Melbourne)
🏢 Planet Pharma
📍 Melbourne