Senior Clinical Research Associate II (Perth or Adelaide)
Core
Monitor clinical trial investigator sites using a risk-based approach to ensure compliance with protocols and regulations, ensuring data accuracy and investigational product integrity.
Role type
Senior Clinical Research Associate (IC)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical and biotech clients
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Risk-based monitoring, Root cause analysis, FDA/ICH GCP regulations, Medical terminology, Investigator site initiation, Data review (SDR/SDV/CRF), Travel management
Preferred skills
Mentoring new monitors, Process improvement, Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites for compliance and data accuracy, Conduct on-site and remote monitoring activities, Initiate and close out clinical trial sites, Escalate and resolve site deficiencies, Mentor team members, Travel 60-80% to site locations
Seniority
Senior, hands-on IC