Company Description

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 integral 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)
- 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 re

📌 Medical Monitor (Buenos Aires)
🏢 Psi Cro
📍 Buenos Aires