Medical Monitor (US Board-Certified Gastroenterologist) Job at PSI CRO, Memphis, TN

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  • PSI CRO
  • Memphis, TN

Job Description

Overview

Company Description: PSI is a leading Contract Research Organization with more than 29 years in the industry, offering a 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 the United States

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
  • Participate in bid defense meetings
  • 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
  • US 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
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.

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Job Tags

Contract work, Work from home,

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