Sr CRA I/II - FSP - Spain
Core
Senior Clinical Research Associate monitoring investigator sites to ensure protocol compliance, data accuracy, and regulatory adherence for clinical trials.
Role type
Senior IC Clinical Research Associate (Cell Therapy)
Builds
Clinical trial sites and monitoring activities for pharmaceutical and biotech clients
Domain
Life Sciences / Clinical Research / Cell Therapy
Required skills
Risk-based monitoring, Root cause analysis, ICH GCP compliance, Investigational product inventory, Site initiation, Trial close-out, Regulatory audit response
Preferred skills
Cell therapy experience, Medical terminology knowledge, CTMS proficiency, Process improvement
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; Conduct on-site and remote monitoring activities including SDV/SDR/CRF review; Initiate and close out clinical trial sites; Respond to regulatory audits and inspections; Track trial status and update study systems.
Seniority
Senior, hands-on IC