Medical Monitor (US Board-Certified Gastroenterologist) at PSI CRO

United States

<h3>Company Description</h3><p>PSI is a leading Contract Research Organization with more than 29 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><h3>Job Description</h3><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 the United States</u></p><p><strong>Responsibilities:</strong></p><ul><li>Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters</li><li>Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations</li><li>Review and analysis of clinical data to ensure the safety of study participants in clinical studies</li><li>Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments</li><li>Address safety issues across the study from sites and the study team</li><li>Review listings for coded events to verify Medical Dictionary for Regulatory activities</li><li>Participate in bid defense meetings</li><li>Assist in Pharmacovigilance activities</li><li>Identify Program risks, and create and implement mitigation strategies with Clinical Operations</li><li>Ability to organize and lead clinical development advisory boards and safety monitoring boards</li><li>Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines</li><li>Review and sign off clinical documents with respect to medical relevance.</li></ul><h3>Qualifications</h3><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>Full working proficiency in English</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><h3>Additional Information</h3><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>