The ProKidney Medical Monitor is a licensed US based physician, preferably internist with knowledge of cardio-metabolic-renal diseases or trained nephrologist who oversees the safety, integrity, and compliance of clinical trials, ensuring that research is conducted in accordance with protocol, Good Clinical Practice (GCP), ethical standards, and regulatory requirements.

Core Responsibilities

• Safety Oversight: Evaluate potential risks, review ongoing safety of trial participants, and assess adverse events (AEs) and serious adverse events (SAEs) for causality, severity, and collaborates as needed with PV teams.

• Protocol & Study Design: Provide medical expertise for protocol development, study design, and clinical study reports; align study objectives with best practices and patient safety priorities.

• Data Review: Analyze clinical data, lab results for screened and enrolled participants, and electronic data to detect early warning signs of safety issues or protocol deviations. Provides medical coding supervision.

• Regulatory Compliance: Ensure adherence to ICH-GCP, FDA/EMA guidelines, and institutional policies; participate in data safety monitoring boards and meetings as needed.

• Investigator and CRO Liaison: Serve as the additional point of contact for clinical investigators, and CRO medical monitors responding to protocol-related queries, and safety reporting.

• Decision-Making: Discusses at weekly medical monitors meetings or other study meetings data that pertains to the safety measures based on trial data.

• Reporting: reports into Clinical Development line function and presents during weekly MM meetings and discusses unclear or complex clinical trial data and potential deviations.

• Collaboration: Coordinate work with other team members in Clinical Development and Clinical Operations, CRAs to address potential protocol deviations, improve recruitment, and reduce noncompliance risks. Participates in the monthly medical and safety meetings within ProKidney and with the CRO.

• Workload: approximately 20 hours spread over week (about 4 hours daily).

Skills & Qualifications

• Medical Education and Expertise: 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.

• Regulatory Knowledge: Familiarity with GCP, FDA/EMA guidelines, and trial ethics.

• Analytical Skills: Ability to interpret complex clinical data and identify trends.

• Communication: Clear, professional communication with investigators, sponsors’ team members, and CRO medical teams.

• Documentation and use of electronic clinical study data: Meticulous record-keeping to support audits and inspections. Experience with MEDIDATA and/or other EDC systems used in clinical trials.