Study Start-Up Associate II/Sr | Part-Time (0.6–0.8 FTE) | ANZ

About the Role

We're looking for a Study Start-Up Associate II/Sr to join our ANZ team on a part-time basis (0.6–0.8 FTE). You'll manage and coordinate study start-up activities across clinical trials, working closely with project teams to ensure sites are activated on time and in compliance with ICH-GCP and local regulatory requirements.

For candidates interested in a full-time position, there may be the opportunity to supplement hours with additional administrative activities to bring the role up to 1.0 FTE.

What You'll Be Doing

• Writing and QC of country-specific and site-specific Participant Information Sheets and Consent Forms
• Preparing and coordinating initial and amended HREC/Ethics Committee and Regulatory Authority submissions
• Collecting, reviewing and QC-ing essential document packages
• Supporting site contract negotiations, budget discussions and contract execution
• Filing study start-up documents in the TMF in line with SOPs and project-specific plans
• Contributing to country do-ability and site feasibility assessments
• Providing SSU status updates to internal teams and clients as needed

What You'll Need

Must have:

• 2+ years' experience in study start-up or a similar role within a CRO, biopharma company or trial site
• Direct, hands-on experience with Australian HREC/ethics submissions and regulatory requirements
• Strong working knowledge of ICH-GCP
• Experience on Phase I–III commercial clinical trials
• Exceptional attention to detail and a first-time-quality mindset
• Strong written and verbal communication skills
• Proficiency in Microsoft Office (Word, Excel, Outlook)
• Ability to manage multiple projects with competing deadlines

Preferred:

• Experience with New Zealand HDEC/ethics submissions and regulatory requirements
• Experience working on global or multi-country trials
• Bachelor's degree in medical or life sciences

Why Join Us?

You'll be part of a collaborative, experienced ANZ start-up team working across a diverse portfolio of clinical trials. We value flexibility, professional development and people who take pride in getting things right the first time.

Interested? Apply now or reach out for a confidential conversation.