Medical Monitor, US Board-Certified Gastroenterologist

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🧪 Clinical Research

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

📋 Description

• Act as the primary point of contact for trial-specific medical and safety-related questions • Provide input for responses to regulatory authorities and IRBs/IECs • 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 protocols • Develop and review trial-specific medical monitoring documents • Manage ongoing trial risks related to medical monitoring • Perform ongoing medical review of operational clinical trial databases • Support Medical Reviewers assigned to trials • Review protocol deviations, RAE reports, SAE narratives, IND/SUSAR safety reports, and clinical study reports • Support Pharmacovigilance, Medical Data Review, and Data Management with safety and database reconciliation • Participate in trial-related committees, including IDMC and adjudication committees • 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/region • Participate in bid defense meetings and client interactions • Act as a medical expert and provide therapeutic expertise to other PSI departments

🎯 Requirements

• Medical Doctor degree required • US Board Certification in Gastroenterology required • Minimum of 10 years of experience practicing Gastroenterology • Clinical Research experience preferred • Proficiency with MS Office applications • Communication, presentation, and analytical skills • Problem-solving, team-oriented, and detail-oriented • Must not require work visa sponsorship for employment now or in the future • Must be based in the United States

🏖️ Benefits

• Employees can work remotely • Full-time employment • Opportunity to join PSI's international Medical Monitoring team • Career development on the frontline of medical science • Opportunity to use medical expertise to help bring new medications to patients

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