CRA I/CRA II/Sr CRA - FSP
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site processes, and guarantee data reliability for pharmaceutical clinical trials.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical sponsors
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, critical thinking, problem-solving, ICH-GCP knowledge, regulatory compliance, site initiation, trial close-out, data review (SDR/SDV/CRF), investigator payment processing, travel management
Preferred skills
Medical/therapeutic area knowledge, clinical trial management systems proficiency, process improvement initiatives
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 data reviews and inventory checks; Initiate and close out clinical trial sites; Ensure essential study documents are complete and audit-ready; Provide trial status tracking and progress reports to management; Facilitate communication between sites, clients, and project teams; Perform frequent travel to site locations (60-80%)
Seniority
Mid-level, hands-on IC