Medical Monitor (Gastroenterologist)

PSI CRO·São Paulo, SP, Brazil

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About the role

Remote, home-based Medical Monitor role in Brazil for a Medical Doctor with at least 10 years of experience practicing as a Gastroenterologist. Responsibilities include medical and safety oversight of global clinical trials, regulatory and ethics committee support, safety reporting, protocol and study report review, audit preparation, and therapeutic expertise. Clinical research experience is preferred. Full working proficiency in English and Portuguese is required.

Key requirements

• Medical Doctor degree required
• At least 10 years of relevant experience
• Required skills: Practicing Gastroenterology, Clinical safety review, Medical monitoring, Clinical trial medical and safety support, Protocol deviation review, Safety report and SAE narrative review, Clinical study report review, Medical expertise in clinical research, MS Office applications, Communication, Presentation, Analytical skills, Problem-solving, Teamwork, Attention to detail, English proficiency, Portuguese proficiency
• Required languages: English, Portuguese

Opportunity details

• Workplace: Remote
• Posted: Nov 6, 2026
• Original advert language: English

Full vacancy

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Employer’s role description

Job title: Medical Monitor (Gastroenterologist)

Location: São Paulo, SP, Brazil

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 reconciliation of safety and operational clinical trial databases
Reviews 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 deliverable
Prepares for and participates in trial audits, follows up on audit findings
Participates in feasibility assessment of potential and ongoing trials in the country/region
Participates in bid defense meetings and other interactions with clients
Acts as a medical expert and provides therapeutic expertise to other PSI departments

Medical Monitor (Gastroenterologist)

About the role

Key requirements

Opportunity details

Full vacancy

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