---
title: "Medical Monitor (US Board-Certified Gastroenterologist) at PSI CRO – All Job Board"
---

# Medical Monitor (US Board-Certified Gastroenterologist) at PSI CRO

Written by

[admin](https://alljobboard.com/author/admin/)

in

- [USA (Remote)](https://maps.google.com/maps?q=USA%20%28Remote%29&zoom=14&size=512x512&maptype=roadmap&sensor=false)
- Posted 4 days ago

![PSI CRO](https://alljobboard.com/wp-content/plugins/wp-job-manager/assets/images/company.png)

 **PSI CRO**

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 global clinical studies and advise the teams and business partners, while always focusing on patients’ safety and well-being.

Home-Based in United States

**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 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

Qualifications

- Medical Doctor degree required
- US Board Certification in Gastroenterology required
- Experience as a practicing Gastroenterology (minimum of 10 years)
- Clinical Research experience preferred
- Proficiency with MS Office applications
- Communication, presentation and analytical skills
- Problem-solving, team and detail-oriented

Additional Information

As part of PSI’s Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.

**Source:** this listing was published by [Jobicy](https://jobicy.com/). [View the original posting and apply](https://jobicy.com/jobs/148885-medical-monitor-us-board-certified-gastroenterologist) — applications are handled there, not on this site.

To apply for this job please visit [jobicy.com](https://jobicy.com/jobs/148885-medical-monitor-us-board-certified-gastroenterologist).

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