FSP - CRA (Level I)
Core
Monitors clinical trial investigator sites using a risk-based approach to ensure compliance with protocols and regulations, ensuring data accuracy and resolving site deficiencies.
Role type
Junior Clinical Research Associate (Level I)
Builds
Clinical trial sites and compliant data
Domain
Healthcare / Clinical Trials
Required skills
Risk-based monitoring, Root cause analysis, Data verification (SDR/SDV), Protocol adherence, Regulatory compliance (ICH-GCP), Site initiation, Trial close-out, Deficiency resolution
Preferred skills
Critical thinking, Problem-solving, Business writing, Team collaboration
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites for compliance and data accuracy, Conduct on-site and remote monitoring activities, Initiate and close out clinical trial sites, Resolve site deficiencies and escalate issues, Ensure essential documents are complete per ICH-GCP, Facilitate communication between sites, clients, and internal teams, Track trial status and progress
Seniority
Junior, hands-on IC
