FSP Clinical Research Associate (CRA I, II & Senior) | Sign-On Bonus
Core
Conduct remote or on-site clinical monitoring and site management to ensure protocol and regulatory compliance, manage documentation, and guarantee subject rights and data reliability.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trials for pharmaceutical and biotech sponsors
Domain
Life Sciences / Clinical Research
Deliverable
physical/clinical work
Required skills
Risk-based monitoring, Root cause analysis, Protocol compliance, ICH-GCP guidelines, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory, Audit readiness
Preferred skills
Medical/therapeutic area knowledge, Clinical Trial Management Systems (CTMS), Process improvement
Technologies
Microsoft Office, Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites using risk-based approaches, conduct on-site file reviews, initiate clinical trial sites, ensure trial close-out, respond to regulatory audits, facilitate communication between sites and sponsors.
Seniority
Senior, hands-on IC