Medical Monitor (Canada Board-Certified Gastroenterologist)

PSI CRO; Canada; Remote; CAD 130,000 - 160,000; Full time

Job summary

A leading Contract Research Organization is seeking a Medical Monitor in Canada to provide medical input for global clinical studies. Candidates must be Board-Certified Gastroenterologists with at least 10 years' experience. Responsibilities include advising teams on medical matters and ensuring compliance with safety regulations. This full-time position is home-based, allowing for a flexible work environment while contributing to important clinical research.

Qualifications

• Minimum of 10 years experience as a practicing Gastroenterologist.
• Full working proficiency in English.
• Clinical Research experience preferred.

Responsibilities

• Advise clients and project teams on medical matters.
• Review and analyze clinical data for participant safety.
• Ensure trial compliance with FDA, EMEA, ICH and GCP guidelines.
• Organize and lead clinical development advisory boards.

Skills

Communication

Analytical skills

Problem-solving

Team-oriented

Detail-oriented

Education

Medical Doctor degree

Canada Board Certification in Gastroenterology

Tools

MS Office applications

Job description

Medical Monitor (Canada Board-Certified Gastroenterologist)

Employment type: Full-time

PSI is a leading Contract Research Organization with more than 29 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.

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:

• Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
• Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
• Review and analysis of clinical data to ensure the safety of study participants in clinical studies
• Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
• Address safety issues across the study from sites and the study team
• Review listings for coded events to verify Medical Dictionary for Regulatory Activities
• Assist in Pharmacovigilance activities
• Identify program risks, and create and implement mitigation strategies with Clinical Operations
• Ability to organize and lead clinical development advisory boards and safety monitoring boards
• Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
• Review and sign off clinical documents with respect to medical relevance

Qualifications:

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

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.