Medical Monitor (US Board-Certified Psychiatrist)

This position is a part-time/consultant role for those based anywhere in the United States. 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. Responsibilities: Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questions Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions Monitors trial participant safety Participates in trial participant recruitment boost and retention activities Presents on medical matters at kick-off and investigator meetings Trains trial team in the therapeutic area and medical aspects of the protocol Develops and reviews trial-specific documents within the scope of medical monitoring Manages ongoing trial risks related to medical monitoring Performs ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trial Reviews protocol deviations Reviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues Reviews 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