Sr. CRA Level 1 FSO
Core
Senior Clinical Research Associate conducting risk-based monitoring, site initiation, and audit readiness for clinical trials across pharmaceutical and biotech sectors.
Role type
Senior IC Clinical Research Associate (Level I)
Builds
Clinical trial data integrity and regulatory compliance for sponsors
Domain
Life Sciences / Clinical Research
Required skills
Risk-based monitoring, Root cause analysis, Protocol compliance, ICH-GCP guidelines, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory, Audit readiness, Travel management
Preferred skills
Medical/therapeutic area knowledge, Clinical Trial Management Systems (CTMS), Process improvement
Technologies
Microsoft Office, Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites using risk-based approaches; Initiate and manage clinical trial sites; Ensure audit readiness and document compliance; Track trial status and progress; Conduct on-site file reviews; Facilitate communication between sites, clients, and project teams.
Seniority
Senior, hands-on IC