FSP Clinical Research Associate I/Clinical Research Associate II - Central Poland
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site processes, and guarantee data reliability for clinical trials.
Role type
Clinical Research Associate I / II
Builds
Clinical trial data and compliance status for pharmaceutical and biotech sponsors
Domain
Life Sciences / Clinical Research / Oncology (via careerplan.io/jobs/R-01370575-fsp-clinical-research-associate-iclinical-research-associate-ii-central-poland-at-thermofi)
Required skills
Risk-based monitoring, Root cause analysis, Protocol compliance, ICH-GCP guidelines, Site management, Data review (SDR/SDV/CRF), Investigational product inventory, Regulatory documentation, Clinical trial close-out, Travel management
Preferred skills
Oncology domain knowledge, Medical terminology, Clinical trial management systems
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 and inventory reviews; Initiate and close out clinical trial sites; Ensure essential documents are complete per regulations; Provide trial status tracking and progress reports; Facilitate communication between sites, clients, and internal teams; Perform frequent travel to site locations (60-80%).
Seniority
Mid-level, hands-on IC