Clinical Research Associate II (FSP)
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site documentation, and assess investigational product inventory for pharmaceutical and biotech clinical trials.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trial monitoring and site management processes for top pharmaceutical and biotech clients
Domain
Life Sciences / Clinical Research / Pharmaceutical
Deliverable
client delivery
Required skills
Clinical monitoring, Root cause analysis, Risk-based monitoring, ICH GCP knowledge, Data accuracy review (SDR/SDV/CRF), Investigational product inventory management, Site initiation and close-out
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving, Regulatory compliance expertise
Technologies
Clinical Trial Management Systems
Responsibilities
Monitor investigator sites using risk-based approaches; Ensure data accuracy through document and record 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