Senior Clinical Research Associate
Core
Managing investigator sites for clinical trials to ensure patient safety, quality execution, and compliance with GCP and regulations.
Role type
Senior Clinical Research Associate (Site Monitoring)
Builds
Clinical trial data integrity and patient safety outcomes
Domain
Life Sciences / Clinical Research / Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial monitoring, GCP/ICH regulations, site management, protocol deviation resolution, data query resolution, AE/SAE monitoring, investigational product handling, recruitment support, audit preparation, mentorship
Preferred skills
Oncology therapeutic experience, global clinical trial experience, internal medicine or infectious diseases
Technologies
Trial Master File, electronic monitoring tools, remote monitoring platforms
Responsibilities
Conduct onsite and remote monitoring for site initiation, routine checks, and close-out; resolve protocol-related issues and data queries; monitor site-level adverse events and collaborate on safety reporting; support site recruitment and activation; ensure proper handling and storage of investigational products; mentor junior CRAs; serve as SME for CRA processes.
Seniority
Senior, hands-on IC with mentorship responsibilities
