Medical Monitor Contractor

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 CR