FSP Clinical Research Associate I/ Clinical Research Associate II
Core
Conduct remote or on-site clinical monitoring and site management to ensure protocol and regulatory compliance for pharmaceutical and biotech clinical trials.
Role type
Clinical Research Associate (I/II)
Builds
Clinical trial data integrity and regulatory compliance
Domain
Life Sciences / Clinical Research
Required skills
Risk-based monitoring, Root cause analysis, Data verification (SDR/SDV), Protocol adherence, ICH-GCP knowledge, Site initiation, Audit readiness, Travel management
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving, Team collaboration
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; Ensure data accuracy through document and record review; Initiate and close out clinical trial sites; Maintain audit readiness and essential documents; Track trial status and provide progress reports; Facilitate communication between sites, clients, and internal teams.
Seniority
Mid-level, hands-on IC
