Medical Monitor

Participant Safety & Clinical Oversight:

• Provide on-call medical coverage during screening, check-in, dosing, and confinement periods for Phase I studies.
• Review and approve subject eligibility based on medical history, laboratory results, and protocol criteria.
• Respond promptly to medical emergencies and direct escalation of care.

Dose Escalation & Safety Review:

• Participate in Safety Review Committee meetings and provide medical input on dose-escalation decisions.
• Review real-time safety data to inform stopping rules and dose-escalation criteria.
• Communicate safety findings to sponsors, principal investigators, and ethics committees.

Protocol & Regulatory Support:

• Review study protocols and informed consent forms for medical accuracy prior to study initiation.
• Ensure compliance with Good Clinical Practice, ICH guidelines, and FDA regulations.
• Support development of medical monitoring plans and safety narratives.

Cross-Functional Collaboration:

• Collaborate with principal investigators, clinical research coordinators, and nursing staff.
• Provide medical training to clinical staff on protocol-specific safety procedures.
• Participate in investigator meetings and sponsor teleconferences.