Medical Monitor – US Board-Certified Psychiatrist

🔥 0 minutes ago

🇺🇸 United States – Remote

⏱ Part Time

🟠 Senior

🔴 Lead

👻 Ghost score 10%

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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 boost 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 • Review protocol deviations, RAE reports, SAE narratives, IND/SUSAR safety reports, and annual IND reports • Support Pharmacovigilance, Medical Data Review, and Data Management with safety and database reconciliation • Participate in trial-related committees such as IDMC and adjudication committees • Review clinical study reports, including safety narratives and TFLs • Provide medical expertise and therapeutic expertise to PSI departments and trials • 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

🎯 Requirements

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

🏖️ Benefits

• Remote work • Opportunity to join PSI's international Medical Monitoring team • Career development on the frontline of medical science • Opportunity to help bring new medications to patients