Clinical Trial Start-Up Coordinator

Fortrea; Sydney; On-site; AUD 70,000 - 95,000; Full time

Job summary

Fortrea is seeking a Study Start-up Associate (Clinical Trial Assistant) to act as primary contact with study sites during maintenance and startup, ensuring essential documents are collected for ethical and regulatory submissions within agreed timelines.

You will support senior staff to compile submissions to Ethics and Regulatory Authority, monitor study documents, adapt patient-facing materials as needed, and keep tracking systems up to date in line with ICH/GCP standards.

Qualifications

• University/College degree in life sciences or related allied health field.
• Minimum 1+ years of clinical trial experience.
• Knowledge of ICH, HREC, RGO and related guidelines.
• Understanding of the clinical trial process.

Responsibilities

• Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner
• Collect and track all necessary documents and perform quality review, formatting, and compilation of final documents for effective and compliant site activation and maintenance
• Assist senior staff to compile, prepare, submit, and obtain approval of submission documents to Ethics/Regulatory Authority in accordance with local requirements
• Ensure all assigned maintenance and start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines
• Update study documents when there are changes in study personnel or study amendments
• Ensure high quality documents are filed and systems are updated on an ongoing and timely basis
• Update status reports, applicable logs, and tracking systems as applicable for projects
• Adapt Informed Consent Forms and other patient facing material to country specific requirements with guidance from line manager and experienced colleagues
• Liaise with internal and external vendors in the generation of Regulatory Authority submissions
• Escalate study issues appropriately and in a timely fashion

Skills

Clinical trial experience

ICH/GCP knowledge

Regulatory submissions

Education

Life science degree

Nursing certification

Medical or laboratory technology

Job description

Fortrea is seeking a Study Start-up Associate (Clinical Trial Assistant) to act as primary contact with study sites during maintenance and startup, ensuring essential documents are collected for ethical and regulatory submissions within agreed timelines.

You will support senior staff to compile submissions to Ethics and Regulatory Authority, monitor study documents, adapt patient-facing materials as needed, and keep tracking systems up to date in line with ICH/GCP standards.