CRA - FSP - Central/Southern Poland
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site processes, and guarantee data reliability for pharmaceutical clinical trials.
Role type
Level II Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical sponsors
Domain
Life Sciences / Clinical Research / Oncology
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, investigator payment processing, clinical trial management systems
Preferred skills
Oncology experience, medical/therapeutic area knowledge, Microsoft Office proficiency, English language skills, presentation skills
Responsibilities
Monitor investigator sites using risk-based approaches to identify and resolve compliance issues; initiate and close out clinical trial sites; conduct on-site file reviews; provide trial status tracking and progress reports; facilitate communication between sites, clients, and project teams; respond to audits and inspections; maintain administrative tasks like expense reports and timesheets.
Seniority
Mid-level IC (3+ years experience)