Clinical Research Associate
Core
Monitor clinical trial sites to ensure compliance with protocols, regulations, and Good Clinical Practice (GCP) while managing study supplies and data integrity.
Role type
Clinical Research Associate (Site Monitoring)
Builds
Clinical studies for prescription medicines
Domain
Biopharmaceuticals / Clinical Research
Deliverable
client delivery
Required skills
ICH-GCP knowledge, site monitoring, regulatory compliance, study drug handling, data query resolution, adverse event reporting, site qualification, risk-based quality management (RbQM)
Preferred skills
Risk-Based Quality Management (RbQM) experience, specific therapeutic area knowledge
Technologies
Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF)
Responsibilities
Conduct site initiation, monitoring, and closure visits; manage study supplies and drug accountability; resolve data queries and report adverse events; prepare and maintain Investigator Study Files (ISF) and eTMF; support site start-up and regulatory submissions.
Seniority
Mid-level, hands-on IC