FSP Sr CRA - Medical Device - Central US
Core
Senior Clinical Research Associate conducting risk-based monitoring, site management, and regulatory compliance for medical device and pharmaceutical clinical trials.
Role type
Senior Clinical Research Associate (Level I)
Builds
Clinical trial data integrity and regulatory compliance
Domain
Clinical Research / Medical Devices / Pharmaceuticals
Required skills
Risk-based monitoring, Root cause analysis, Protocol compliance, ICH-GCP guidelines, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory, Audit readiness
Preferred skills
Medical/therapeutic area knowledge, Clinical Trial Management Systems (CTMS), Travel adaptability
Technologies
Microsoft Office, Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites using risk-based approach; Ensure data accuracy through document review; Initiate and manage clinical trial sites; Conduct on-site file reviews; Respond to regulatory audits and inspections.
Seniority
Senior, hands-on IC