Senior Clinical Research Associate (Melbourne or Sydney)
Core
Monitor clinical trial investigator sites using risk-based monitoring to ensure compliance with protocols and regulations, ensuring data accuracy and investigational product integrity.
Role type
Senior Clinical Research Associate (Level II)
Builds
Clinical trial data and compliance for pharmaceutical and biotech clients
Domain
Clinical Research / Life Sciences
Required skills
Risk-based monitoring, Root cause analysis, FDA/ICH GCP regulations, Clinical trial initiation and close-out, Investigator site identification, Data review (SDR/SDV/CRF), Mentoring, Regulatory audit response
Preferred skills
Registered Nursing certification, Experience with Clinical Trial Management Systems (CTMS), Travel flexibility (60-80%)
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites with risk-based approach, Ensure data accuracy through SDR/SDV/CRF review, Initiate and close out clinical trial sites, Escalate and resolve site deficiencies, Mentor new team members, Respond to regulatory audits and inspections
Seniority
Senior, hands-on IC