CRA (Level I)
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site processes, and guarantee data reliability for pharmaceutical and biotech clinical trials.
Role type
Junior Clinical Research Associate (IC)
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 management, Data verification (SDR/SDV/CRF), Investigational product inventory, Regulatory documentation, Clinical trial close-out, Travel management
Preferred skills
Medical terminology, Anatomy knowledge, Clinical trial management systems (CTMS), Process improvement
Technologies
Microsoft Office, Clinical Trial Management Systems
Responsibilities
Monitor investigator sites using risk-based approaches to identify and resolve compliance issues; Conduct on-site and remote monitoring activities including data review and product inventory; Initiate and close out clinical trial sites; Ensure essential documents are complete per ICH-GCP; Provide trial status tracking and progress reports; Respond to audits and inspections; Manage frequent travel to site locations (60-80%).
Seniority
Junior, entry-level IC