Clinical Research Associate II
Core
Monitor clinical investigative sites for Phase I-III studies to ensure protocol execution, regulatory compliance, and subject safety.
Role type
Senior Clinical Research Associate (Site Monitoring)
Builds
Clinical study execution and data quality 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 selection, travel management
Preferred skills
Health-related tertiary qualification (Medical, Scientific, Nursing), therapeutic area expertise
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; oversee site personnel activities without direct authority; ensure quality and timely submission of data and safety reports; train site personnel on protocols; manage investigator payments and negotiate agreements; identify and evaluate potential investigators/sites.
Seniority
Mid-Senior level, hands-on IC