Senior Clinical Research Associate / Clinical Research Associate II
Core
Conducts remote and on-site clinical study monitoring to ensure data integrity and patient safety across investigator sites.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial execution and regulatory compliance for biotech, medtech, and specialty pharma clients.
Domain
Clinical Research / Life Sciences
Deliverable
physical/clinical work
Required skills
Clinical trial monitoring, data integrity verification, site qualification, study initiation, close-out monitoring, TMF/eTMF management, ICH/GCP compliance, travel and expense management
Preferred skills
None stated
Technologies
eTMF systems
Responsibilities
Deliver quality, timely monitoring reports for sponsor approval; monitor studies (remote, onsite, or other approved modes) focusing on data integrity and patient safety; plan day-to-day monitoring activities and set site priorities; conduct on-site qualification, study initiation, interim, and close-out monitoring visits; maintain Trial Master File (TMF)/eTMF per ICH/GCP guidelines; review and verify site documents for accuracy and completeness.
Seniority
Senior, hands-on IC
