Senior Clinical Research Associate
Core
Monitor clinical trial investigator sites using risk-based approaches to ensure compliance with protocols and regulations, manage data accuracy, and resolve site deficiencies.
Role type
Senior Clinical Research Associate (Level I)
Builds
Clinical trial operations for pharmaceutical and biotech clients
Domain
Clinical research / Life sciences
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, data verification (SDR/SDV/CRF), regulatory compliance (FDA/ICH GCP), site initiation and close-out, investigator management, medical terminology
Preferred skills
Mentoring new monitors, process improvement, travel adaptability
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites for compliance and data accuracy, initiate and close out clinical trial sites, document observations and escalate issues, conduct file reviews, facilitate communication between sites and clients, mentor team members
Seniority
Senior, hands-on IC