Clinical Research Associate II
Core
Ensures successful protocol-level execution of clinical studies by monitoring clinical investigative sites, ensuring regulatory compliance, and managing site personnel to meet study objectives.
Role type
Clinical Research Associate II
Builds
Clinical trial execution for investigational drugs or devices
Domain
Clinical research / Pharmaceutical trials
Deliverable
client delivery
Required skills
Site qualification, interim monitoring, study closeout, regulatory compliance (GCPs, ICH Guidelines), data quality assurance, safety event reporting, investigator payment management, site selection and negotiation
Preferred skills
Tertiary qualification in health-related disciplines, risk-based monitoring approach, knowledge of specific therapeutic areas, advanced knowledge of local regulatory requirements
Technologies
Monitoring tools and resources
Responsibilities
Conduct site qualification, initiation, interim monitoring, and study closeout visits; ensure adherence to federal regulations and GCPs; monitor activities of clinical investigative sites; train study site personnel on protocol and regulatory requirements; manage investigator payments and negotiate agreements; identify and evaluate new potential investigators/sites; ensure regulatory inspection readiness; ensure quality and timely submission of data including safety events.
Seniority
Mid-level, hands-on IC