Medical Monitor Contractor

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.

Documentation and use of electronic clinical study data:

Meticulous record-keeping to support audits and inspections.

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.

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.