Medical Monitor Contractor

ProKidney is seeking a licensed US-based physician, preferably an internist with expertise in cardio-metabolic-renal diseases or a trained nephrologist, to oversee the safety, integrity, and compliance of clinical trials.

Responsibilities

• Evaluate potential risks, review ongoing safety of trial participants, and assess adverse events (AEs) and serious adverse events (SAEs) for causality, severity, and collaborate as needed with PV teams.
• Provide medical expertise for protocol development, study design, and clinical study reports; align study objectives with best practices and patient safety priorities.
• Analyze clinical data, lab results for screened and enrolled participants, and electronic data to detect early warning signs of safety issues or protocol deviations; provide medical coding supervision.
• Ensure adherence to ICH-GCP, FDA/EMA guidelines, and institutional policies; participate in data safety monitoring boards and meetings as needed.
• Serve as a point of contact for clinical investigators and CRO medical monitors, responding to protocol-related queries and safety reporting.
• Discuss safety measures based on trial data during weekly medical monitor meetings or other study meetings.
• Report into the Clinical Development line function and present during weekly MM meetings, discussing unclear or complex clinical trial data and potential deviations.
• Coordinate with other team members in Clinical Development and Clinical Operations, CRAs to address potential protocol deviations, improve recruitment, and reduce noncompliance risks.
• Participate in monthly medical and safety meetings within ProKidney and with the CRO.

Requirements

• MD, licensed and board-eligible or preferably board-certified internist with a strong clinical background in the trial’s therapeutic area, or nephrologist with experience in cell therapy.
• Phase 3 industry trial medical monitoring experience required.
• Familiarity with GCP, FDA/EMA guidelines, and trial ethics.
• Ability to interpret complex clinical data and identify trends.
• Clear, professional communication with investigators, sponsors’ team members, and CRO medical teams.
• Meticulous record-keeping to support audits and inspections; experience with MEDIDATA and/or other EDC systems used in clinical trials.

Schedule

Approximately 20 hours spread over the week (about 4 hours daily).