Medical Monitor (US Board-Certified 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. Job Description 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 questionsProvides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questionsMonitors trial participant safetyParticipates in trial participant recruitment boost and retention activitiesPresents on medical matters at kick-off and investigator meetingsTrains trial team in the therapeutic area and medical aspects of the protocolDevelops and reviews trial-specific documents within the scope of medical monitoringManages ongoing trial risks related to medical monitoringPerforms ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trialReviews protocol deviationsReviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issuesReviews 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 databasesReviews 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 deliverablePrepares for and participates in trial audits, follows up on audit findingsParticipates in feasibility assessment of potential and ongoing trials in the country/regionParticipates in bid defense meetings and other interactions with clientsActs as a medical expert and provides therapeutic expertise to other PSI departments Qualifications Medical Doctor degree requiredUS Board Certification in Gastroenterology requiredExperience as a practicing Gastroenterology (minimum of 10 years)Clinical Research experience preferredProficiency with MS Office applicationsCommunication, presentation and analytical skillsProblem-solving, team and detail-oriented For this position, PSI is not hiring individuals who require work visa sponsorship for employment now or in the future. Additional Information 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.