Senior Clinical Research Associate
Core
Responsible for site qualification, initiation, interim monitoring, site management, and study close-out visits to ensure data quality and regulatory compliance.
Role type
Senior Clinical Research Associate (Lead CRA)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical/biotech studies
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Site monitoring, protocol adherence, source document verification, regulatory compliance (GCP/FDA/EU), data query resolution, training site staff, travel management
Preferred skills
Lead CRA coordination, Clinical Monitoring Plan development, bid defense participation, study tool design
Technologies
IxRS, EDC systems, Microsoft Office
Responsibilities
Conduct feasibility, initiation, interim, and close-out site visits; coordinate global study CRAs; review trip reports and provide feedback; mentor less experienced CRAs; verify source documents for compliance and data veracity; review CRFs and assist with data queries; maintain Investigator Site File and Trial Master File documentation; ensure IP accountability; participate in protocol design and investigator meetings.
Seniority
Senior, hands-on IC with leadership responsibilities