Medical Monitor (Gastroenterologist)

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 Argentina

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)