Clinical Research Associate II (FSP)
Core
Coordinate clinical monitoring and site management for pharmaceutical and biotech clinical trials, ensuring protocol and regulatory compliance.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trial data integrity and regulatory compliance for global pharmaceutical and biotech clients
Domain
Clinical Research / Life Sciences
Deliverable
physical/clinical work
Required skills
Clinical monitoring, Risk Based Monitoring (RBM), Root Cause Analysis (RCA), ICH GCP knowledge, Protocol adherence, Investigational product management, Site initiation, Trial close-out, Regulatory compliance
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites using risk-based approaches; Ensure data accuracy via SDR, SDV, and CRF review; Escalate and resolve site deficiencies; Conduct on-site file reviews and trial close-outs; Identify and initiate new clinical trial sites; Provide trial status tracking and progress reports.
Seniority
Mid-level, hands-on IC
