Senior CRA - FSP - Medical Device - US Central/West Coast
Core
Senior Clinical Research Associate conducting risk-based monitoring, site management, and audit readiness for medical device and pharmaceutical clinical trials.
Role type
Senior IC Clinical Research Associate (Level I)
Builds
Clinical trial data integrity and regulatory compliance for sponsors
Domain
Life Sciences / Clinical Research / Medical Devices
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, protocol compliance, ICH-GCP knowledge, site initiation, data review (SDR/SDV/CRF), investigator management, audit preparation
Preferred skills
Medical/therapeutic area knowledge, problem-solving, travel adaptability
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approach; initiate and manage clinical trial sites; ensure audit readiness and document compliance; track trial status and update study systems; conduct on-site file reviews; facilitate communication between sites, clients, and project teams.
Seniority
Senior, hands-on IC