Sr. Field Clinical Research Specialist
Core
Field-based clinical research specialist managing clinical trial sites, overseeing study execution, patient recruitment, and regulatory compliance for Medtronic's cardiac catheterization products.
Role type
Senior Field Clinical Research Specialist
Builds
Clinical trial data, study materials, and regulatory submissions for Phase I-IV cardiac device trials
Domain
Medical Devices / Cardiology / Clinical Research
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial design and execution, GCP and FDA regulation compliance, IRB/IEC submission management, patient recruitment and retention, source document verification, adverse event reporting, CTMS system proficiency, protocol development and amendment review
Preferred skills
Experience in cardiac catheterization lab environments, knowledge of 21 CFR Parts 11, 50, 54, 56, 312, 812
Technologies
Veeva Vault CTMS, Oracle Siebel CTMS, Salesforce
Responsibilities
Coordinate study start-up, site initiation, monitoring, and close-out; Prepare and revise Clinical Investigation Plans; Train investigators and site staff on product usage and trial protocols; Manage patient recruitment and retention strategies; Verify source documents and report adverse events; Ensure HIPAA and ICH-GCP compliance; Direct lab staff on product utilization
Seniority
Senior, hands-on IC
