FSP CRA (Level I)
Core
Conduct remote or on-site clinical monitoring and site management to ensure protocol and regulatory compliance, manage documentation, and guarantee subject rights and data reliability for pharmaceutical and biotech clients.
Role type
Junior Clinical Research Associate (Level I)
Builds
Clinical trials for top 50 pharmaceutical companies and 750+ biotechs
Domain
Life Sciences / Clinical Research / Pharmaceutical
Required skills
Risk-based monitoring, Root cause analysis, Critical thinking, Problem-solving, Data accuracy verification (SDR/SDV/CRF), Investigational product inventory, Regulatory compliance (ICH-GCP), Site initiation, Trial close-out, Essential document management, Travel management
Preferred skills
Medical/therapeutic area knowledge, Medical terminology, Clinical trial management systems, Process improvement
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches to identify failures and implement corrective actions; Ensure data accuracy through source data review and case report form review; Conduct physical inventory and records review of investigational products; Initiate clinical trial sites and perform trial close-out; Maintain essential documents and ensure audit readiness; Provide trial status tracking and progress reports; Facilitate communication between sites, clients, and internal teams; Perform frequent travel (60-80%) to site locations including overnight stays.
Seniority
Junior, hands-on IC
