Project Support Associate/Senior Project Support Associate

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 a Project Support Associate (PSA) to join our growing team in Australia. As a PSA at Southern Star, you’ll work in an exciting and fast-paced environment, providing critical administrative support to our clinical operations and project management teams.

This is an excellent development opportunity for candidates looking to build a career in clinical research.

Reporting to the Senior Clinical Team Leader, you’ll be responsible for:

Quality Systems and Compliance;

• Conduct quality control review of data entered into systems for your assigned projects
• Work with project managers to ensure the Trial Master File is inspection ready
• Conduct QC reviews of documents within the eTMF
• Manage and track study level system access across a range of platforms
• Ensure appropriate assignment and tracking of study specific training

Project Tracking and Reporting

• Support the Project Manager to maintain study specific trackers
• Prepare regular project metric reports and status updates using project systems

Project Communication

• Actively participate in project meetings, including coordination of invitations, assisting with preparation materials, minute taking, action log maintenance and presentation of metrics
• Facilitate communication between project team members as required

Project Coordination and Delivery

• Support the project manager to develop essential document templates for assigned projects and load project plan templates into the eTMF
• Manage, track and distribute ancillary trial supplies to and from investigational sites
• Support site payments and invoicing
• Assist with preparation and tracking of IRB/IEC/RA and other local submissions

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

• Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines.
• High degree of computer literacy, including full Office 365 suite, Proven capability to learn and work within other systems
• Excellent planning and organisational skills, with the ability to work on competing projects and tight deadlines
• Collaborative approach to work

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
• 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.