FSP CRA (Level II)
Core
Performs and coordinates clinical monitoring and site management processes, conducting remote or on-site visits to assess protocol and regulatory compliance.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trial operations for life sciences sponsors and PPD
Domain
Clinical research / Life sciences
Required skills
Risk-based monitoring, Root cause analysis, Protocol compliance, ICH-GCP guidelines, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory, Regulatory documentation, Trial close-out
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving, Microsoft Office, English language proficiency
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites using risk-based approaches; Conduct on-site and remote monitoring visits; Initiate clinical trial sites; Ensure audit readiness and document completeness; Track trial status and progress; Facilitate communication between sites, clients, and project teams.
Seniority
Junior, hands-on IC