Australian CRA: On‑Site Monitoring & Trial Compliance

Sironax; Australia; Remote; AUD 85,000 - 110,000; Full time

Job summary

Sironax is seeking a proactive Clinical Research Associate (CRA) to monitor and manage clinical trial sites across Australia. The role ensures adherence to the protocol, SOPs, ICH-GCP, and Australian regulations, interfacing with investigative sites and the clinical operations team.

The CRA will perform site management, SDV, IP accountability, and provide ongoing study process training to site staff, with frequent domestic travel (60-70%).

Qualifications

• University degree in Life Sciences, Pharmacy, Nursing or related field.
• Solid understanding of ICH-GCP guidelines and Australian regulatory requirements.

Responsibilities

• Perform on-site monitoring visits and monitor site performance.
• Ensure informed consent and protocol compliance.
• Conduct SDV to verify data accuracy and completeness.
• Manage IP accountability, storage and reconciliation at sites.
• Identify and resolve site issues, deviations and adverse events.

Skills

Site monitoring

Regulatory knowledge

Data verification

Communication

Education

Life Sciences degree

Tools

EDC

CTMS

Microsoft Office

Job description

Sironax is seeking a proactive Clinical Research Associate (CRA) to monitor and manage clinical trial sites across Australia. The role ensures adherence to the protocol, SOPs, ICH-GCP, and Australian regulations, interfacing with investigative sites and the clinical operations team.

The CRA will perform site management, SDV, IP accountability, and provide ongoing study process training to site staff, with frequent domestic travel (60-70%).