Medical Monitor

Responsibilities

• Evaluate potential risks and review ongoing safety of trial participants
• Assess adverse events (AEs) and serious adverse events (SAEs) for causality and severity
• Provide medical expertise for protocol development, study design, and clinical study reports
• Analyze clinical data and lab results to detect safety issues or protocol deviations
• Ensure adherence to ICH-GCP, FDA/EMA guidelines, and institutional policies
• Serve as a point of contact for clinical investigators and CRO medical monitors
• Coordinate with Clinical Development, Clinical Operations, and CRAs to address protocol deviations
• Participate in weekly medical monitor meetings and monthly safety meetings

Requirements

• MD degree with US licensure
• Board-eligible or board-certified Internist (with cardio-metabolic-renal knowledge) or Nephrologist
• Experience in Phase 3 industry trial medical monitoring
• Experience in cell therapy preferred
• Familiarity with GCP, FDA/EMA guidelines, and trial ethics
• Experience with MEDIDATA and/or other EDC systems
• Ability to interpret complex clinical data and identify trends
• Eligibility to work in the United States without sponsorship

About the Company

ProKidney is a biotechnology company focused on advancing cell therapy treatments.