Full-Time Medical Monitor (Nephrologist)

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.

Requirements:

• Medical Doctor degree required
• US Board Certification in Nephrology required
• Experience as a practicing Nephrology (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

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