Medical Monitor (Canada Board-Certified Gastroenterologist)

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          "text": "<p>PSI <strong>Medical Monitors&#xa0;</strong>provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.</p><p><u>Home-Based in Canada</u></p><p><strong>Responsibilities:</strong></p><ul><li>Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questions</li><li>Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions</li><li>Monitors trial participant safety</li><li>Participates in trial participant recruitment boost and retention activities</li><li>Presents on medical matters at kick-off and investigator meetings</li><li>Trains trial team in the therapeutic area and medical aspects of the protocol</li><li>Develops and reviews trial-specific documents within the scope of medical monitoring</li><li>Manages ongoing trial risks related to medical monitoring</li><li>Performs ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trial</li><li>Reviews protocol deviations</li><li>Reviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues</li><li>Reviews IND/SUSAR Safety Reports, updates/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request)</li><li>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)</li><li>Supports Pharmacovigilance, Medical Data Review and Data Management with reconciliation of safety and operational clinical trial databases</li><li>Reviews clinical study reports (CSRs), including safety narratives and tables, figures, and listings (TFLs)</li><li>Provides medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverable</li><li>Prepares for and participates in trial audits, follows up on audit findings</li><li>Participates in feasibility assessment of potential and ongoing trials in the country/region</li><li>Participates in bid defense meetings and other interactions with clients</li><li>Acts as a medical expert and provides therapeutic expertise to other PSI departments</li></ul>",
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