Assistant CRA - FSP (m/f/d)
Core
Remote site management and monitoring for clinical trials, ensuring site compliance and data quality through centralized review and communication.
Role type
Assistant Clinical Research Associate (Remote Monitoring)
Builds
Clinical trial data integrity and site compliance for global therapeutic areas
Domain
Clinical Research / Life Sciences
Required skills
ICH GCP knowledge, risk-based monitoring, root cause analysis, medical terminology, EDC systems, regulatory document review, site performance evaluation, data trend analysis, MS Office proficiency
Preferred skills
Prior clinical research experience (0-1 year), clinical environment experience, formal training in medical terminology/anatomy, aspiration to advance to CRA role
Technologies
EDC systems, CTMS, eTMF, MS Office
Responsibilities
Contact study sites to collect documentation and resolve issues; review study logs and EDC data remotely; conduct site management calls and document findings; evaluate PI oversight and subject safety; investigate site performance using risk-based monitoring; track trial status and violations; assist with audit-ready file preparation and regulatory responses.
Seniority
Entry-level (0-1 year experience)