Job Description

About us

Southern Star Research is a full-service Contract Research Organization (CRO) dedicated to navigating the complexities of bringing new medical products to market. With a legacy of excellence that began 14 years ago in Sydney, we have grown from a small, passionate team into a global network of experts committed to delivering high-quality services in medical writing, clinical monitoring, project management, biostatistics, data management, safety and medical monitoring, and quality assurance.

Southern Star Research has been recognized for its outstanding contributions to the field, winning prestigious awards such as the Frost and Sullivan 2024 Asia-Pacific Competitive Strategy Leadership Award and being named as Great Place to Work in Australia in 2024 and 2025. Our international team continues to deliver innovative clinical trial solutions across diverse therapeutic areas, ensuring the success of every study we manage.

The role

We are looking for an experienced Quality Assurance Associate to join our growing team.

Our head office is in North Sydney, and this role has flexibility to be office based, hybrid or home based anywhere in Australia.

Reporting to the Head of Quality Assurance, you’ll be responsible for:

• Manage and coordinate the company training program, including planning, delivery, induction, and LMS administration in collaboration with subject matter experts and department heads.
• Maintain and monitor training records, trackers, and compliance to ensure all employee training meets organisational and regulatory requirements.
• Support and maintain the Quality Management System (QMS), including documentation, trackers, and training on new or revised procedures.
• Conduct training needs analyses, deliver workshops and specialised training, and identify skill gaps through ongoing monitoring and co-monitoring activities.
• Support audits and reporting by preparing materials, assisting with client audits, producing training/quality metrics, and providing general training and QA guidance.

To be successful in the role, we’re looking for candidates with:

• Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines.
• Minimum of 4 years’ experience working in the clinical research environment including experience in training or learning development role.
  Comprehensive working knowledge of ISO 14155 and ICH GCP guidelines with knowledge of clinical research.
• Experience in developing and writing standard operating procedures.
• Experience facilitating training and using training management systems.
• Exceptional interpersonal skills, including the ability to engage with diverse, cross-functional teams possessing different strengths, skills and perspectives.

Why Southern Star?

• Join a passionate team committed to our shared purpose to create brighter futures, one study at a time.
• Exciting growth phase, creating ongoing career development opportunities for our teams.
• Competitive remuneration.
• Flexible work environment, with hybrid and fully remote options.
• STAR day - one extra day off per year for you to recharge.

Diversity, Equity and Inclusion

At Southern Star Research, we are committed to fostering a safe, inclusive, and respectful workplace where everyone feels valued and empowered to contribute. We celebrate the diversity of our team and recognise the strength that comes from different perspectives, backgrounds, and lived experiences.

We are dedicated to ensuring an inclusive recruitment process and providing equal opportunities for all applicants, regardless of race, ethnicity, gender identity, sexual orientation, age, disability, or cultural background.