State Licensed Medical Monitor

Job Summary

Providing physician-level medical oversight for early-phase clinical trials, the full-time State Licensed Medical Monitor will ensure participant safety, conduct real-time clinical decision-making, and assess adverse events while working remotely.

Key responsibilities

• Provide on-call medical coverage during screening, check-in, dosing, and confinement periods for Phase I studies
• Participate in Safety Review Committee meetings and provide medical input on dose-escalation decisions
• Review study protocols and safety monitoring plans for medical and scientific accuracy prior to study initiation

Required qualifications

• M.D. or D.O. degree from an accredited medical school with an active, unrestricted medical license
• Minimum 5 years of clinical experience in a medical setting
• Minimum 2 years of experience in clinical research, clinical pharmacology, biotechnology, or CRO industry
• Working knowledge of ICH-GCP guidelines, FDA regulations, and human subjects protection requirements
• Strong understanding of pharmacokinetics/pharmacodynamics principles related to dose-escalation safety decisions