PSI CRO

Global CRO delivering on-time patient enrollment

Medical Monitor - Canada Board-Certified Gastroenterologist

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeRemote in CanadaNo salary listedRemote

About the Job

Requirements

A Medical Doctor degree is required.
Canada Board Certification in Gastroenterology is required.
A minimum of 10 years of experience practicing gastroenterology is required.
Proficiency with Microsoft Office applications is required.
Communication, presentation, analytical, problem-solving, teamwork, and attention-to-detail skills are required.

Responsibilities

Act as the primary point of contact for trial-specific medical and safety-related questions.
Provide input for responses to regulatory authorities and Institutional Review Boards or Independent Ethics Committees.
Monitor trial participant safety.
Participate in participant recruitment and retention activities.
Present medical matters at kick-off and investigator meetings.
Train trial teams 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 operational clinical trial databases and support assigned Medical Reviewers.
Review protocol deviations, RAE reports, serious adverse event narratives, safety reports, essential trial records, annual IND reports, clinical study reports, and safety tables, figures, and listings.
Support Pharmacovigilance, Medical Data Review, and Data Management with reconciliation of safety and operational clinical trial databases.
Participate in trial-related independent data monitoring and adjudication committees.
Provide medical expertise and therapeutic expertise to PSI departments and 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 assessments of potential and ongoing trials in the country or region.
Participate in bid defense meetings and client interactions.

Desired Qualifications

Clinical research experience is preferred.

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 Canada

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
Canada 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.

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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