FSP CRA(Level II)
Core
Conducts 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 clinical trials.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trial data and compliance for life sciences therapies
Domain
Life Sciences / Clinical Research
Required skills
Clinical monitoring, Root cause analysis, Risk-based monitoring, ICH-GCP guidelines, Protocol adherence, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory, Regulatory compliance, Trial close-out
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving, Communication, Time management, Digital literacy, English language proficiency
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; Conduct on-site and remote monitoring visits; Initiate and close out clinical trial sites; Ensure document completeness and audit readiness; Track trial status and provide progress reports; Facilitate communication between sites, clients, and project teams; Respond to audits and inspections.
Seniority
Mid-level, hands-on IC
