CRA II
Core
Coordinate clinical monitoring and site management for Phase I-IV trials, ensuring protocol adherence, patient safety, and data integrity across multiple therapeutic areas.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial execution and data quality for pharmaceutical/biotech clients
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Clinical trial monitoring, GCP/ICH guidelines knowledge, site management, data integrity verification, regulatory compliance, medical terminology proficiency, CTMS/eCRF/eTMF systems usage
Preferred skills
Experience with Site Selection, Initiation, Routine Monitoring, and Close Out Visits
Technologies
CTMS, eCRF, eTMF
Responsibilities
Monitor multiple clinical trial sites (remote and on-site), review source data to ensure data integrity, ensure investigator adherence to clinical trial protocol, provide training to site staff, escalate concerns to relevant departments, manage competing priorities and study timelines
Seniority
Mid-level IC