Medical Monitor (US Board-Certified Gastroenterologist)

<h2>Company Description</h2><p>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.</p><h2>Job Description</h2><p>PSI <strong>Medical Monitors </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 United States</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><h2>Qualifications</h2><ul><li>Medical Doctor degree required</li><li>US Board Certification in Gastroenterology required</li><li>Experience as a practicing Gastroenterology (minimum of 10 years)</li><li>Clinical Research experience preferred</li><li>Proficiency with MS Office applications</li><li>Communication, presentation and analytical skills</li><li>Problem-solving, team and detail-oriented</li></ul><h2>Additional Information</h2><p>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.</p>