Oncology Clinical Research Associate – Early-Phase Trials

Icon Oncology Group; Brisbane; On-site; AUD 90,000 - 130,000; Full time

Benefits offered by this job

Health & Wellbeing program

Flexible work arrangements

Generous leave policies

Volunteer time and charitable giving

Learning & Development access

Job summary

Thermo Fisher Scientific Australia is seeking a Senior Clinical Research Associate (Level I) to monitor oncology trial sites and ensure protocol, regulatory and data integrity compliance. The role involves extensive site visits, data verification, and collaboration with the Clinical Team Manager to manage risks and deliver trial milestones.

Candidate should have a life sciences degree or nursing certification, 3+ years of CRA experience, and a strong knowledge of FDA/ICH-GCP guidelines.

Qualifications

• Bachelor's degree in life science or RN certification.
• Valid driver's license where applicable.
• 3+ years of clinical research monitoring experience.
• Equivalency of education, training and related experience may be considered.

Responsibilities

• Monitors investigator sites with risk-based approach and conducts RCA to reduce site risk.
• Ensures data accuracy via SDR, SDV and CRF review during on-site and remote monitoring.
• Documents observations in timely reports using standard business writing.
• Escalates deficiencies to clinical management and tracks resolution.

Skills

Clinical monitoring

FDA guidelines

ICH GCP

Data quality

Mentoring

Education

Bachelor's in life sciences

Registered Nursing certification

Tools

CTMS

Job description

Thermo Fisher Scientific Australia is seeking a Senior Clinical Research Associate (Level I) to monitor oncology trial sites and ensure protocol, regulatory and data integrity compliance. The role involves extensive site visits, data verification, and collaboration with the Clinical Team Manager to manage risks and deliver trial milestones.

Candidate should have a life sciences degree or nursing certification, 3+ years of CRA experience, and a strong knowledge of FDA/ICH-GCP guidelines.