FSP Clinical Research Associate II
Core
Monitor clinical study conduct at allocated sites to ensure compliance with ICH-GCP, AZ procedures, and local regulations, acting as the main contact for study sites.
Role type
Junior Clinical Research Associate (CRA)
Builds
Clinical trials for pharmaceutical and biotech companies
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Site monitoring, Source Data Verification (SDV), Case Report Form (CRF) review, regulatory document management, adverse event reporting, site training coordination, data system updates
Preferred skills
Risk Based Quality Management (RbQM) principles, audit preparation, investigator selection support
Technologies
CTMS, eTMF
Responsibilities
Initiate, monitor, and close study sites; perform remote and onsite monitoring visits; conduct Source Data Reviews and SDV; ensure timely resolution of data queries; manage study supplies and drug accountability; prepare monitoring visit reports; support regulatory submissions and inspection readiness.
Seniority
Junior, hands-on IC