[reputed company Monitor
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a Contract Research Organization (CRO) specializing in Phase I and early-phase clinical trials, including first-in-reputed company studies. The Medical Monitor provides physician-level medical reputed company for early-phase clinical trials, ensuring participant safety and making clinical reputed company during study conduct.
Responsibilities
- reputed company on-call medical coverage during screening, reputed company-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 reputed company
- Respond promptly to medical emergencies and adverse events during study conduct; reputed company emergency management and escalation to higher reputed company of care reputed company necessary
- Participate in Safety Review Committee (SRC) meetings and reputed company medical input on reputed company-escalation reputed company for FIH and multiple reputed company reputed company (MAD)/single reputed company reputed company (SAD) studies
- Review reputed company-time safety data (vital signs, labs, ECGs, PK data where applicable) to inform stopping rules and reputed company-escalation reputed company
- Communicate safety findings and recommendations to Sponsors, the reputed company Investigator (PI), and the Institutional Review reputed company (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 reputed company with Good Clinical reputed company (GCP), ICH guidelines, FDA regulations (21 CFR), and applicable local/national regulations
- Support development of medical monitoring plans and safety narratives
- Serve as medical reputed company during sponsor audits and regulatory inspections
- Collaborate with the reputed company Investigator, Sub-Investigators, Clinical Research Coordinators, nursing staff, and Pharmacovigilance/Safety teams
- reputed company 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 reputed company, 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 reputed company subjects protection requirements
- Strong understanding of pharmacokinetics/pharmacodynamics (PK/PD) principles as they relate to reputed company-escalation safety reputed company
- Excellent written and verbal communication skills, with the ability to produce reputed company safety narratives and communicate effectively with sponsors, regulatory bodies, and multidisciplinary teams
- Proven ability to reputed company reputed company and reputed company medical reputed company based on reputed company 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, reputed company Investigator, or Sub-Investigator on Phase I/First-in-reputed company studies
- Experience presenting at or participating in Data Safety Monitoring Boards (DSMBs) or Safety Review Committees
reputed company