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 knowledge, Medical terminology, Data review (SDR/SDV/CRF), Site initiation and close-out, Regulatory compliance
Preferred skills
Registered Nursing certification, Life sciences degree, Microsoft Office proficiency, English language skills
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 per ICH-GCP; Provide trial status reports; Facilitate communication between sites, clients, and project teams; Respond to audits and inspections.
Seniority
Mid-level, hands-on IC