Senior Study Start Up Specialist

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 Senior Study Start Up Specialist to join our growing team. As a Senior Study Start Up Specialist at Southern Star, you'll work in an exciting and fast-paced environment, assisting the Head of Site Liaison in the execution of a broad range of SSU activities including ethics and regulatory submissions, contracts, budgets and feasibility.

This role has the flexibility to be home based anywhere in Australia. For candidates preferring an office based, or hybrid environment, our office is located in Gordon on Sydney's North Shore.

Reporting to the Head of Site Liaison, you'll be responsible for:

• Managing ethics/governance submissions in line with regulatory requirements
• Develop, review and negotiate site contracts and budgets
• Provide support to project teams in site feasibilities and qualification
• Serve as a key point of contact for study start up for sites
• Identify, evaluate and recommend potential investigators and sites on an ongoing basis

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

• Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines.
• A minimum of 3 years' study start-up experience within a CRO environment
• Contracts/budgets negotiation experience
• Previous experience managing regulatory and ethics submissions
• Excellent planning and organisational skills, with the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
• A sound knowledge and understanding of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations;
• Exceptional communication skills as well as strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity;
• Demonstrated business ethics and integrity;

Why Southern Star?

• Competitive remuneration
• Flexible work environment, with hybrid and fully remote options
• Ongoing opportunities for learning and development
• Office located in Gordon - under cover parking provided and close to public transport;
• 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.