Senior Clinical Research Associate

Location: Australia; current working rights required. The fixed-term role involves 60–70% onsite monitoring per month.

Company

hirify.global supports biotech, medtech, and specialty pharma companies in developing medicines, medical devices, and diagnostics.

What you will do

• Prepare quality, timely monitoring reports for sponsor approval in line with the Clinical Monitoring Plan.
• Monitor clinical trials remotely, onsite, or through another approved monitoring mode, focusing on data integrity and patient safety.
• Plan monitoring activities and priorities for assigned investigator sites.
• Prepare for and conduct site qualification, study initiation, interim monitoring, and close-out visits.
• Review clinical deliverables, identify and escalate quality issues, and monitor study scope, timelines, and budget parameters.
• Maintain the TMF/eTMF and verify that site documents are accurate, complete, current, and compliant with filing requirements.

Requirements

• Degree or equivalent experience in a clinical, scientific, or health-related field; licensed healthcare professionals may also qualify.
• At least 4 years of clinical trial experience as a CRA and completion of a CRA training program.
• Experience coaching or mentoring other CRAs.
• Experience monitoring complex or global trials.
• Working knowledge of FDA guidance, EU directives, local regulations, ISO 14155, drug/device development, and clinical monitoring procedures.
• Current working rights in Australia are required.

Culture & Benefits

• Fixed-term contract for 4 months.
• Flexible working practices intended to support work-life balance.
• Opportunities for professional growth, skill development, and mentoring.
• Opportunity to contribute to medical innovation and patient-focused clinical research.