About the Opportunity
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.
- Collaborative culture where individuals are encouraged to take ownership and make a visible impact.
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Quality & Training Associate in Melbourne employer: Planet Pharma
At Planet Pharma, we pride ourselves on being an exceptional employer, particularly for the Nurse Unit Manager - Clinical Trials role located in the vibrant Newcastle / Greater Sydney area. Our commitment to employee growth is evident through our supportive work culture that fosters collaboration and accountability, alongside competitive salaries and comprehensive benefits. With a focus on professional development and a strong emphasis on quality patient care, we offer a unique opportunity to lead a dedicated team in delivering impactful clinical research while enjoying the perks of working in a dynamic and award-winning environment.
