Clinical Research Associate
Core
Monitor clinical trial progress and ensure compliance with protocols, SOPs, GCP, and regulations across multiple sites and therapeutic areas.
Role type
Senior Clinical Research Associate (IC)
Builds
Clinical trials for patients
Domain
Biopharma / Clinical Research
Required skills
ICH/GCP guidelines, clinical trial process knowledge, site feasibility assessment, risk assessment, data quality assurance, stakeholder management, training delivery, root cause analysis, regulatory compliance, travel management
Preferred skills
Pharmaceutical/biotech sponsor experience, Investigator site experience, leadership and mentoring, global communication skills
Technologies
CTMS, eDC, eTMF, Microsoft Office Suite
Responsibilities
Identify and assess potential investigators and sites; conduct pre-study and initiation visits; perform on-site and off-site monitoring; ensure data completeness and quality; train site staff; manage site closure; escalate issues and implement corrective actions; support regulatory submissions and audits.
Seniority
Senior, hands-on IC with leadership responsibilities