CRA II / Sr CRA - FSP - Austria
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site processes, and guarantee data reliability for pharmaceutical and biotech clinical trials.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for sponsors in the pharmaceutical and biotech sectors
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk-based monitoring, root cause analysis, critical thinking, problem-solving, ICH-GCP knowledge, regulatory compliance, site initiation, trial close-out, data review (SDR/SDV/CRF), physical inventory management, audit response
Preferred skills
Medical/therapeutic area knowledge, Clinical Trial Management System (CTMS) proficiency, presentation skills
Technologies
Microsoft Office, Clinical Trial Management Systems
Responsibilities
Monitor investigator sites using risk-based approaches to identify and resolve compliance issues; Conduct on-site and remote monitoring activities including data review and inventory checks; Initiate and close out clinical trial sites; Ensure essential documents are complete and audit-ready; Track trial status and provide progress reports to management; Facilitate communication between sites, clients, and project teams; Respond to regulatory audits and inspections.
Seniority
Senior, hands-on IC
