Company DescriptionPSI 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 DescriptionPSI 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 StatesResponsibilities: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.
, 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 clin.