CRA I/II - FSP - EMEA
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
Clinical Research Associate (Level I/II)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical sponsors
Domain
Life Sciences / Clinical Research / Oncology
Deliverable
client delivery
Required skills
Clinical monitoring, Risk Based Monitoring (RBM), Root Cause Analysis (RCA), Protocol adherence, ICH-GCP guidelines, Site initiation, Trial close-out, Investigational product inventory, Data review (SDR/SDV/CRF)
Preferred skills
Oncology experience, Medical terminology knowledge, Clinical Trial Management Systems (CTMS)
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 verification and inventory checks; Initiate and close out clinical trial sites in collaboration with clients; Ensure essential documents are complete and audit-ready; Provide trial status tracking and progress reports to management; Respond to regulatory audits and inspections.
Seniority
Mid-level, hands-on IC