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PSI CRO

Global CRO delivering on-time patient enrollment

Medical Monitor - Gastroenterologist

Biology & BiotechConfirmed live in the last 24 hours
Full-timeRemote in MexicoNo salary listedRemote

About the Job

Requirements

  • A Medical Doctor degree is required.
  • At least 10 years of experience practicing gastroenterology.
  • Proficiency with Microsoft Office applications.
  • Communication, presentation, and analytical skills.
  • Problem-solving ability, teamwork, and attention to detail.

Responsibilities

  • Act as the primary point of contact for trial-specific medical and safety-related questions for all parties.
  • Provide input for responses to regulatory authorities and Institutional Review Boards or Independent Ethics Committees on trial-specific medical and safety-related questions.
  • Monitor trial participant safety.
  • Participate in trial participant recruitment and retention activities.
  • Present on medical matters at kick-off and investigator meetings.
  • Train the trial team in the therapeutic area and medical aspects of the protocol.
  • Develop and review trial-specific documents within the scope of medical monitoring.
  • Manage ongoing trial risks related to medical monitoring.
  • Perform ongoing medical review of the operational clinical trial database and support assigned Medical Reviewers.
  • Review protocol deviations.
  • Review RAE reports, write and/or review SAE narratives, support the Pharmacovigilance team with outstanding safety queries, and interact with the sponsor on site safety issues.
  • Review IND/SUSAR Safety Reports, updates and amendments to essential trial records, and annual IND reports with sponsor data as requested by the sponsor.
  • Participate in managing trial-related committees, such as independent data monitoring or adjudication committees, as described in trial-specific charters.
  • Support Pharmacovigilance, Medical Data Review, and Data Management with reconciliation of safety and operational clinical trial databases.
  • Review clinical study reports, including safety narratives and tables, figures, and listings.
  • Provide medical expertise as needed in trials where medical monitoring is not a contract deliverable.
  • Prepare for and participate in trial audits, and follow up on audit findings.
  • Participate in feasibility assessment of potential and ongoing trials in the country or region.
  • Participate in bid defense meetings and other interactions with clients.
  • Act as a medical expert and provide therapeutic expertise to other PSI departments.

Desired Qualifications

  • Clinical research experience is preferred.

About the Company

PSI CRO

Global CRO delivering on-time patient enrollment

PSI CRO is a global contract research organization that handles clinical trials for multiple therapeutic areas, with a focus on enrolling patients on schedule and delivering studies on time. Its services span feasibility assessments, trial planning, site selection, patient recruitment, and multi-continent trial execution across 50+ countries, backed by medical doctor resources dedicated to accurate timeline predictions. Unlike many CROs, PSI emphasizes predictable enrollment and on-time project delivery, aiming for high client satisfaction and repeat business through a pragmatic, no-nonsense approach. The company’s goal is to be regarded as the best CRO in the world by both clients and employees, achieved through reliable timelines, strong execution, and low staff turnover.

Company size
1,001-5,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Switzerland
Founded
1995

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