MedicalMonitor(Gastroenterologist)

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. 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 Mexico 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 cli