Our Client headquartered in Sydney, are a clinical-stage biotechnology company dedicated to developing revolutionary treatments that enable patients and their families to live their best lives.
Currently expanding their clinical operations we are seeking a passionate and driven Clinical Research Associate to support their studies across their Australian sites in QLD, NSW & WA.
This is a unique opportunity to be part of a purpose-driven, collaborative, and fast-moving team.
About the Role
As a Clinical Research Associate, you’ll take full ownership of the site management and monitoring cycle from site selection through to closeout. You’ll be instrumental in the success of the clinical trial, working closely with internal teams, study sites, and third-party vendors to ensure high-quality data collection, compliance, and timely delivery.
You will manage multiple sites (with the option for remote monitoring at select locations), oversee patient recruitment strategies, and support all aspects of study execution—helping drive real impact for patients and caregivers.
Key Responsibilities
- Full accountability for site management across Phase 1–3 trials
- Perform study site monitoring visits (initiation to close-out)
- Drive patient recruitment, site start-up, and engagement strategies
- Ensure adherence to protocols, ICH-GCP, and regulatory requirements
- Maintain clinical trial systems (CTMS, EDC, eCOA, IRT, safety platforms)
- Conduct budget and contract negotiations at the site level
- Deliver training to site staff and internal stakeholders
- Prepare investigator meeting presentations
- Identify risks and implement mitigation plans
- Manage and monitor serious adverse event reporting and ethics submissions
- Liaise with Principal Investigators and study site staff for screening and data accuracy
- Bachelor’s degree in a scientific, health-related, or technical field
- Minimum 2 years’ experience as a CRA or clinical monitor
- Experience in site start-up and managing multi-site trials
- Strong understanding of GCP, ICH Guidelines, FDA regulations
- High-level attention to detail and strong documentation skills
- Excellent written and verbal communication
- Ability to work independently and manage multiple projects in a fast-paced environment
- Proficiency with Microsoft Office and eClinical platforms
- Completion of core GCP training (ARCS Australia preferred)
- Willingness to travel across Australia as needed
- Be part of a growing Australian biotech making a real impact to patients' lives
- Work with a supportive and visionary team committed to innovation
- Enjoy flexibility with remote monitoring options
- Opportunity to influence trial strategy, systems implementation, and process improvements
- Contribute to meaningful research
