Medical Monitor (US Board-Certified Gastroenterologist)
# Medical Monitor (US Board-Certified Gastroenterologist) **PSI CRO** · United States · `Remote` · `Full Time` 💼 **Уровень роли:** `Senior` 🕒 **Статус:** *Опубликовано: сегодня* · *Источник: Himalayas (JSON API)* --- ### Top Skills & Match 🎯 **Ключевой стек роли:** `[Medical-Monitoring]` `[Clinical-Research]` `[Pharmacovigilance]` `[Gastroenterology]` `[Pharmaceutical-Research]` `[Medical-Monitor]` `[Gastroenterologist]` `[Gastroenterology-Physician]` `[Medical-Oversight-Physician]` `[Gastroenterology-Specialist]` `[Remote-Physician-Clinical-Reviewer-GI]` --- ### About the Role PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being. Home-Based in United States Responsibilities: - Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questions - Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions - Monitors trial participant safety - Participates in trial participant recruitment boost and retention activities - Presents on medical matters at kick-off and investigator meetings - Trains trial team in the therapeutic area and medical aspects of the protocol - Develops and reviews trial-specific documents within the scope of medical monitoring - Manages ongoing trial risks related to medical monitoring - Performs ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trial - Reviews protocol deviations - Reviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues - Reviews IND/SUSAR Safety Reports, updates/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request) - Participates in management of trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) as described in the corresponding trial-specific charter(s) - Supports Pharmacovigilance, Medical Data Review and Data Management with reconciliation of safety and operational clinical trial databases - Reviews clinical study reports (CSRs), including safety narratives and tables, figures, and listings (TFLs) - Provides medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverable - Prepares for and participates in trial audits, follows up on audit findings - Participates in feasibility assessment of potential and ongoing trials in the country/region - Participates in bid defense meetings and other interactions with clients - Acts as a medical expert and provides therapeutic expertise to other PSI departments - Medical Doctor degree required - US Board Certification in Gastroenterology required - Experience as a practicing Gastroenterology (minimum of 10 years) - Clinical Research experience preferred - Proficiency with MS Office applications - Communication, presentation and analytical skills - Problem-solving, team and detail-oriented As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them. PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Originally posted on Himalayas
- Medical-Monitoring
- Clinical-Research
- Pharmacovigilance
- Gastroenterology
- Pharmaceutical-Research
- Medical-Monitor
- Gastroenterologist
- Gastroenterology-Physician
- Medical-Oversight-Physician
- Gastroenterology-Specialist
- Remote-Physician-Clinical-Reviewer-GI
- Medical-Affairs
Наблюдалась 2026-10-03, впервые 2026-10-03, найдена на 2 площадках, источник — Himalayas (JSON API).