Senior CRA (Level I)
Core
Conducts remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site processes, and guarantee data reliability for clinical trials.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and site compliance for pharmaceutical and biotech clients
Domain
Life Sciences / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk-based monitoring, Root cause analysis, ICH-GCP guidelines, Protocol adherence, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory, Regulatory compliance, Audit readiness, Project tracking
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving, Team collaboration, Process improvement
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches, Ensure data accuracy through document review, Initiate and close out clinical trial sites, Manage investigator payments and meetings, Escalate and resolve site deficiencies, Conduct on-site file reviews and quality checks
Seniority
Senior, hands-on IC