Clinical Research Associate – Full‑time (Sydney)

About the role

Join MSD as a permanent, full‑time Clinical Research Associate based in Macquarie Park, Sydney. The role offers competitive remuneration, flexible home‑or‑office working, and the chance to manage protocol performance and compliance across assigned sites.

Key responsibilities

• Act as primary site contact and manager for allocated clinical research sites, building strong relationships throughout all trial phases.
• Perform site management and monitoring activities in line with ICH‑GCP, sponsor procedures, local regulations and protocol requirements.
• Coordinate site readiness, conduct remote and on‑site monitoring visits, and prepare comprehensive visit reports.
• Collect, review and maintain regulatory documentation in CTMS, eTMF and related systems.
• Identify, assess and resolve site performance, quality and compliance issues, escalating when necessary.
• Support audit and inspection activities and contribute to CRA team knowledge sharing.

Required profile

• Associate degree or higher in a scientific or healthcare discipline with direct site management experience in a biotech, pharma or CRO environment.
• Strong understanding of clinical research, trial phases, GCP/ICH requirements and local clinical research laws.
• Proven site management capability, including patient recruitment and monitoring.
• Excellent communication skills in English and the local language, with strong organisational and problem‑solving abilities.

Required skills

• Adverse Event Reporting System
• Clinical Research
• Clinical Research Methods
• Clinical Site Management
• Clinical Study Management
• Clinical Trial Planning
• Clinical Trials Monitoring
• Data Analysis
• Data Documentation
• Data Reporting
• Document Management
• Good Clinical Data Management Practice (GCDMP)
• Good Clinical Practice (GCP)
• Microsoft Office
• Clinical applications on computer, tablet and mobile devices

What we offer

• Competitive remuneration and benefits package.
• Opportunities for career growth and professional development within a collaborative, matrixed environment.