Sydney-Based Study Startup Specialist II

Psi CRO; Sydney; Hybrid; AUD 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid work (2 WFH days)

Onsite parking

Learning & development

Mental wellness program

Novated leasing

Global industry exposure

Job summary

PSI CRO in Sydney, Australia, is seeking a Study Startup Specialist II for an 18-month contract to support increased project demands. You will lead startup activities, coordinate site budgets, ethics submissions and TMF maintenance, while working in a hybrid model.

The role requires at least 2 years in clinical research, a bachelor’s degree, excellent communication in English, and strong MS Office skills, with a focus on study activation timelines and regulatory documentation.

Qualifications

• At least 2 years of industry experience in clinical research as a Study Startup Specialist, or similar position with practical study startup experience in Australia.
• 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

• Maintains study-specific and corporate startup tracking systems
• Facilitates site budgets and contract negotiations
• Supports site regulatory document collection
• Under supervision, may prepare initial and amendment submission dossiers to competent authorities, ethics committees, and/or site submission dossiers (as applicable)
• Communicates with the project team and investigational sites throughout the entire duration of the study
• Develops site specific startup timelines and enrollment projections and is responsible for meeting the site activation milestones
• May review study specific translations
• Supervises Trial Master File (TMF) maintenance throughout the study startup phase

Skills

Communication skills

English proficiency

MS Office proficiency

Education

Bachelor's degree or above in pharmaceutical/healthcare

Tools

MS Office (Word, Excel, PowerPoint, Outlook)

Job description

PSI CRO in Sydney, Australia, is seeking a Study Startup Specialist II for an 18-month contract to support increased project demands. You will lead startup activities, coordinate site budgets, ethics submissions and TMF maintenance, while working in a hybrid model.

The role requires at least 2 years in clinical research, a bachelor’s degree, excellent communication in English, and strong MS Office skills, with a focus on study activation timelines and regulatory documentation.