CRA (Level I)
Core
Clinical Research Associate I performing on-site and remote monitoring of investigator sites to ensure clinical trials comply with protocols and regulations.
Role type
Junior IC clinical research associate (monitoring)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical/medical device studies
Domain
Life Sciences / Clinical Research
Deliverable
physical/clinical work
Required skills
Source data verification (SDV), risk-based monitoring, ICH-GCP knowledge, site compliance assessment, investigational product accountability, root cause analysis, clinical trial systems proficiency
Preferred skills
Life Sciences/Pharmacy/Medicine degree, 2+ years clinical monitoring experience, medical terminology knowledge, English fluency
Technologies
Clinical Trial Management System (CTMS), Microsoft Office
Responsibilities
Conduct on-site and remote monitoring visits; perform source data review and verification; assess site compliance with protocol and GCP; review investigational product inventory; document monitoring observations; escalate and resolve site issues; maintain study documentation and CTMS data; support audits and inspections.
Seniority
Junior, hands-on IC