Clinical Research Associate 3

📋 Description

• Support pre-market and post-market clinical studies to ensure regulatory compliance.
• Collaborate with clinical managers, CTAs, data management, and biostatisticians.
• Manage site start-up/activation and regulatory documentation.
• Coordinate IRB/EC submissions and amendments to study documents.
• Conduct on-site or remote visits for qualification, initiation, monitoring, and close-out.
• Oversee source data verification in EDC or CRFs for accuracy.

🎯 Requirements

• Experience in medical device trials and clinical/outcomes research design.
• Advanced knowledge of ISO 14155, 21 CFR Parts 11, 50, 54, 812, and related regs.
• Knowledge of ICH/GCP and clinical monitoring requirements.
• Certification/education in clinical research preferred; hospital experience desired.
• Strong communication, organization, and cross-functional collaboration skills.
• Experience with ICF/CRF development and regulatory submissions; budget/contract negotiation.

🎁 Benefits

• Equal opportunity employer; vaccination requirements may apply depending on role.