Note: The job is a remote job and is open to candidates in USA. Celerion is a Contract Research Organization (CRO) specializing in Phase I and early-phase clinical trials, including first-in-human studies. The Medical Monitor provides physician-level medical oversight for early-phase clinical trials, ensuring participant safety and making clinical decisions during study conduct.
Responsibilities
- Provide on-call medical coverage during screening, check-in, dosing, and confinement periods for Phase I studies, including FIH and healthy volunteer trials
- Review and approve subject eligibility based on medical history, physical examination, laboratory results, ECGs, and protocol-specified inclusion/exclusion criteria
- Respond promptly to medical emergencies and adverse events during study conduct; direct emergency management and escalation to higher levels of care when necessary
- Participate in Safety Review Committee (SRC) meetings and provide medical input on dose-escalation decisions for FIH and multiple ascending dose (MAD)/single ascending dose (SAD) studies
- Review real-time safety data (vital signs, labs, ECGs, PK data where applicable) to inform stopping rules and dose-escalation criteria
- Communicate safety findings and recommendations to Sponsors, the Principal Investigator (PI), and the Institutional Review Board (IRB)/Ethics Committee as required
- Review study protocols, informed consent forms, and safety monitoring plans for medical and scientific accuracy prior to study initiation
- Ensure medical procedures comply with Good Clinical Practice (GCP), ICH guidelines, FDA regulations (21 CFR), and applicable local/national regulations
- Support development of medical monitoring plans and safety narratives
- Serve as medical liaison during sponsor audits and regulatory inspections
- Collaborate with the Principal Investigator, Sub-Investigators, Clinical Research Coordinators, nursing staff, and Pharmacovigilance/Safety teams
- Provide medical training and guidance to clinical staff on protocol-specific safety procedures
- Participate in investigator meetings, sponsor teleconferences, and internal safety review discussions
Skills
- 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 (PK/PD) principles as they relate to dose-escalation safety decisions
- Excellent written and verbal communication skills, with the ability to produce clear safety narratives and communicate effectively with sponsors, regulatory bodies, and multidisciplinary teams
- Proven ability to make timely and sound medical decisions based on complex clinical data
- Detail-oriented approach with the ability to multitask and manage priorities in a fast-paced environment
- Strong leadership qualities with the ability to mentor and guide junior staff members
- Prior experience serving as a Medical Monitor, Principal Investigator, or Sub-Investigator on Phase I/First-in-Human studies
- Experience presenting at or participating in Data Safety Monitoring Boards (DSMBs) or Safety Review Committees
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