General role description

Regulatory Start-Up Specialists coordinate the early regulatory and ethical approvals required to initiate clinical trials. They ensure that submissions to ethics committees, regulators, and research sites are accurate, compliant, and completed on time.

By working across internal teams and external stakeholders, they play a key role in ensuring clinical studies are set up efficiently and in line with national and international requirements.

Key responsibilities

• Prepare and submit documentation required to initiate clinical trials, including submissions to the Therapeutic Goods Administration (TGA), Human Research Ethics Committees (HRECs), and research governance offices
• Monitor timelines and maintain accurate records of regulatory and ethics submissions, approvals, and correspondence
• Liaise with clinical project managers, legal teams, regulatory affairs, and contract managers to align start-up deliverables
• Ensure documentation complies with Australian regulations, Good Clinical Practice (GCP), and international clinical research standards
• Assist with the development and review of standard operating procedures (SOPs), start-up plans, and submission templates
• Maintain clinical trial tracking systems and contribute progress updates to project teams and internal stakeholders.