Clinical Study Start-Up Associate I – Hybrid

Psi CRO; Sydney; Hybrid; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work arrangement

Onsite parking

Learning and professional development

Mental wellness programs

Novated leasing options

Job summary

PSI is a leading CRO with a global footprint and a strong presence in Australia. We seek a clinical research professional to support start-up activities for Australian studies, coordinating with project teams and sites from contracts to activation.

This role offers ownership of timelines and cross-functional collaboration in a dynamic, quality-driven environment. You will maintain start-up trackers, assist with regulatory dossiers, and ensure TMF quality while working in a hybrid setup with two

Qualifications

• Minimum of 1 year of experience in clinical development including start-up process
• Experience with EC submissions
• Bachelor’s degree or above, preferred in pharmaceutical/healthcare related majors
• Excellent communication skills, both written and verbal
• Full working proficiency in English
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook)

Responsibilities

• Maintain study-specific and corporate startup tracking systems
• Facilitate site budgets and contract negotiations
• Support site regulatory document collection
• Under supervision, may prepare initial/amendment submission dossiers to ethics committees, and/or site submission dossiers
• Communicates with the project team and investigational sites throughout the study lifecycle
• Develop site specific startup timelines and enrollment projections and be responsible for meeting the site activation milestones
• May review study specific translations
• Responsible for maintaining the Trial Master File (TMF) for assigned tasks throughout the study lifecycle

Skills

Clinical start-up experience

Regulatory submissions experience

English proficiency

Communication skills

Education

Bachelor’s degree or above, pharmaceutical/healthcare preferred

Tools

MS Office

Job description

PSI is a leading CRO with a global footprint and a strong presence in Australia. We seek a clinical research professional to support start-up activities for Australian studies, coordinating with project teams and sites from contracts to activation.

This role offers ownership of timelines and cross-functional collaboration in a dynamic, quality-driven environment. You will maintain start-up trackers, assist with regulatory dossiers, and ensure TMF quality while working in a hybrid setup with two