Australia Study Startup Specialist – 12-Month Contract

Psi Cro Ag; Sydney; Hybrid; AUD 90,000 - 110,000; Full time

Benefits offered by this job

Hybrid work arrangement with WFH days

Onsite parking

Learning & development

Mental wellness programs

Novated leasing options

Job summary

PSI CRO AG in Australia seeks an SSU Specialist I for a 12-month contract to support study startup activities. The role is based in Macquarie Park, Sydney, with hybrid work options and growth opportunities in a global clinical research environment.

You will maintain startup tracking, assist with budgets and contracts, manage regulatory documents, and coordinate with sites and the project team to ensure timely study activation.

Qualifications

• Minimum 1 year industry experience in clinical research and/or 1 year of Study Startup experience in Australia.

Responsibilities

• Maintains study-specific startup tracking systems.
• Facilitates site budgets and contract negotiations.
• Supports site regulatory document collection.
• May prepare initial and amendment submission dossiers to authorities/ethics committees.
• Communicates with project team and investigational sites throughout the study.
• Develops site startup timelines and enrollment projections to meet activation milestones.
• May review study translations.
• Supervises TMF maintenance during startup.

Skills

Communication skills

MS Office proficiency

Education

Bachelor’s degree or higher

Tools

MS Office

Job description

PSI CRO AG in Australia seeks an SSU Specialist I for a 12-month contract to support study startup activities. The role is based in Macquarie Park, Sydney, with hybrid work options and growth opportunities in a global clinical research environment.

You will maintain startup tracking, assist with budgets and contracts, manage regulatory documents, and coordinate with sites and the project team to ensure timely study activation.