Sr CRA (Level I)
Core
Senior Clinical Research Associate conducting risk-based monitoring, site management, and regulatory compliance for clinical trials in pharmaceutical and biotech sectors.
Role type
Senior Clinical Research Associate (Level I)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical and biotech 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
Infectious disease, Respiratory, Ophthalmology, Oncology clinical studies
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approach, Conduct on-site and remote monitoring visits, Ensure protocol and regulatory compliance, Manage site initiation and close-out, Prepare monitoring reports and correspondence, Participate in investigator meetings, Respond to audits and inspections
Seniority
Senior, hands-on IC