Clinical Research Associate II
Core
Primary sponsor point of contact for investigative sites, ensuring protocol compliance, patient safety, and successful recruitment/retention across diverse therapeutic areas.
Role type
Senior Clinical Research Associate (CRA II)
Builds
Clinical studies for innovative medicines
Domain
Biopharmaceuticals / Clinical Research
Required skills
Site evaluation and monitoring, protocol adherence, patient recruitment strategies, risk assessment, regulatory compliance (GCP/ICH), data quality assurance, investigator management, audit readiness, adverse event reporting
Preferred skills
Risk-based monitoring approach, Healthy Volunteer and First-in-Patient trial experience, therapeutic area expertise, cross-functional collaboration
Technologies
Clinical trial monitoring tools, site engagement platforms
Responsibilities
Conduct on-site and off-site monitoring, train and motivate site staff, evaluate recruitment techniques, mentor junior CRAs, manage investigator payments, ensure audit readiness, report adverse events within 24 hours
Seniority
Mid-Senior, hands-on IC with mentorship duties
