Senior CRA 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
Senior Clinical Research Associate (Level II)
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), investigator management, audit readiness
Preferred skills
Medical/therapeutic area knowledge, clinical trial management systems, process improvement
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches to identify and resolve compliance issues; conduct on-site and remote monitoring activities including data and inventory reviews; initiate and close out clinical trial sites; facilitate communication between sites, clients, and project teams; respond to regulatory audits and inspections.
Seniority
Senior, hands-on IC