FSP CRA II
Core
Clinical Research Associate responsible for site evaluation, monitoring visits, risk assessment, and ensuring study compliance with ICH GCP and local regulations.
Role type
Mid-level Clinical Research Associate (CRA)
Builds
Clinical trials execution at investigator sites
Domain
Clinical Research / Pharmaceutical
Required skills
ICH GCP knowledge, Risk Based Quality Management (RBQM), site evaluation, monitoring visits, data query resolution, safety reporting, source document review, recruitment management, regulatory compliance, stakeholder communication
Preferred skills
Local regulatory knowledge (e.g., EUCTR), remote monitoring proficiency, root cause analysis
Technologies
RBQM systems, EDC, CTMS, IRT, eTMF
Responsibilities
Perform site evaluation, initiation, on/off-site monitoring, and close-out visits; conduct local risk assessments; ensure adherence to ICH GCP and sponsor standards; manage recruitment and retention; resolve data queries and safety reports; maintain inspection-ready records.
Seniority
Mid-level, hands-on IC