Clinical Trial Start-Up Specialist — Sydney

Fortrea; Sydney; On-site; AUD 60,000 - 80,000; Full time

Job summary

Fortrea in Sydney is seeking a Start-up Associate (Clinical Trial Associate) to serve as primary contact with investigative sites during study maintenance and startup activities, ensuring essential regulatory documents are collected and submissions are made on time.

You will support senior staff with ICH/GCP compliance, adapt consent forms for country requirements, and liaise with internal teams and vendors to prepare regulatory authority submissions.

Qualifications

• University/College degree (life science preferred) or equivalent in related field.
• 0–2 years of experience in clinical trials or regulatory roles.
• Basic understanding of ICH, RA, IRB/IEC and related guidelines.

Responsibilities

• Develop awareness of regulatory legislation and practice with support from senior staff.
• Assist senior staff to compile, submit, and obtain approvals for regulatory submissions to IRB/IEC/Third body/Regulatory Authority.
• Liaise with internal and external vendors for regulatory submissions and quality review.
• Review final submission documents for accuracy and compliance.
• Prepare and organize submission-related communications within Fortrea.
• Escalate study issues in a timely manner and support management as needed.

Skills

Regulatory knowledge

Documentation control

IRB familiarity

Site liaison

Education

University/College degree (life science preferred)

Job description

Fortrea in Sydney is seeking a Start-up Associate (Clinical Trial Associate) to serve as primary contact with investigative sites during study maintenance and startup activities, ensuring essential regulatory documents are collected and submissions are made on time.

You will support senior staff with ICH/GCP compliance, adapt consent forms for country requirements, and liaise with internal teams and vendors to prepare regulatory authority submissions.