Senior Clinical Research Associate
Core
Primary point of contact at clinical trial sites, responsible for overseeing quality, integrity, and compliance of trial sites in accordance with protocols, SOPs, ICH GCP, and regulatory requirements.
Role type
Senior Clinical Research Associate (monitoring)
Builds
Clinical trial data integrity and regulatory compliance at site level
Domain
Pharmaceutical/Biotech clinical trials
Required skills
Clinical trial monitoring, Protocol adherence, GCP compliance, Regulatory requirements knowledge, Site management, Stakeholder communication, Quality assurance, SOP implementation, Risk management, Data integrity
Preferred skills
Pharma/Biotech Sponsor employment experience, Clinical study coordinator experience, Drug discovery/development process experience, Mentor/coach capability
Technologies
Clinical trial management systems (CTMS), Electronic Data Capture (EDC), Regulatory databases
Responsibilities
Monitor clinical trial sites for protocol and GCP compliance, Ensure data quality and integrity, Manage internal and external stakeholders, Conduct site visits and audits, Mentor junior staff, Resolve site-related issues
Seniority
Senior, hands-on IC