FSP CRA(Level II)
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
Clinical Research Associate (Level II)
Builds
Clinical trial data integrity and regulatory compliance for sponsors
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical monitoring, Risk Based Monitoring (RBM), Root Cause Analysis (RCA), ICH-GCP guidelines, Protocol adherence, Site management, Investigational product inventory, Regulatory compliance, Data review (SDR/SDV/CRF), Audit readiness
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving, Travel adaptability
Technologies
Clinical Trial Management Systems (CTMS), 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 review and product inventory; Initiate and close out clinical trial sites; Ensure essential documents are complete and audit-ready; Facilitate communication between sites, clients, and project teams; Respond to regulatory audits and inspections.
Seniority
Mid-level, hands-on IC