Clinical Start-Up Specialist – Hybrid Work (AU)

Psi CRO; Sydney; Hybrid; AUD 70,000 - 110,000; Full time

Benefits offered by this job

Hybrid work arrangement

Onsite parking

Learning and development

Mental wellness programs

Novated leasing

Global organization

Job summary

PSI is seeking a clinical research professional to support successful start-up of clinical studies in Australia. You will collaborate with project teams and sites, coordinating from contracts and regulatory docs to site activation.

Role fits candidates with startup experience, strong communication, and English fluency, and offers a hybrid work arrangement with on-site activities in Sydney.

Qualifications

• 1+ year in clinical development with startup experience.
• Experience with EC submissions.
• Bachelor’s degree or higher; pharma/healthcare preferred.
• Excellent written and verbal communication.
• Full working proficiency in English.
• MS Office proficiency (Word/Excel/PowerPoint).

Responsibilities

• Maintain startup tracking systems for studies.
• Facilitate site budgets and contract negotiations.
• Support site regulatory document collection.
• Under supervision, prepare initial/amendment submissions to ethics committees and site dossiers.
• Communicate with project teams and investigational sites throughout the study lifecycle.
• Develop site startup timelines and enrollment projections; meet activation milestones.
• Maintain the Trial Master File (TMF) for assigned tasks.

Skills

Clinical start-up

EC submissions

MS Office

English proficiency

Communication skills

Education

Bachelor’s degree or above

Job description

PSI is seeking a clinical research professional to support successful start-up of clinical studies in Australia. You will collaborate with project teams and sites, coordinating from contracts and regulatory docs to site activation.

Role fits candidates with startup experience, strong communication, and English fluency, and offers a hybrid work arrangement with on-site activities in Sydney.