Clinical Research Associate II (GTA)
Core
Monitor clinical investigative sites for Phase I-III studies to ensure protocol execution, regulatory compliance, and data quality.
Role type
Clinical Research Associate (monitoring)
Builds
Clinical study execution and regulatory compliance at investigative sites
Domain
Biopharmaceuticals / Clinical Research
Required skills
Clinical trial monitoring, GCP/ICH guidelines knowledge, regulatory compliance, site qualification, data quality assurance, safety event reporting, investigator contract management, site identification, travel management
Preferred skills
Health-related tertiary qualification (Medical, Scientific, Nursing), therapeutic area knowledge
Technologies
Microsoft Office Suite, clinical trial systems
Responsibilities
Conduct site qualification, initiation, interim monitoring, and closeout visits; ensure adherence to federal/local regulations and SOPs; train site personnel on protocols; manage investigator payments and agreements; identify potential investigators/sites; ensure regulatory inspection readiness.
Seniority
Mid-level, hands-on IC