Senior Clinical Research Associate

🔥 1 hour ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 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

• Conduct and report all types of onsite monitoring visits • Participate in study startup, if applicable • Perform CRF review, source document verification and query resolution • Manage site communication • Supervise study activities, timelines and schedules at the country level • Serve as a point of contact for in-house support services and vendors • Participate in quality control, including compliance monitoring and report review • Participate in feasibility research • Support the regulatory team in preparing documents for study submissions • Build and maintain relationships with clinical sites and investigators • Ensure timelines, targets and clinical research standards • Focus on subjects’ rights, safety, well-being and data quality compliance

🎯 Requirements

• College/University degree in Life Sciences or an equivalent combination of education, training & experience • Minimum 5 years of independent on-site monitoring experience in the USA • Experience in all types of monitoring visits in Phase I–III • Participation in clinical projects as a Senior Monitor • Experience monitoring complex Oncology trials required • Experience with radiopharmaceuticals and/or breast cancer preferred • Experience monitoring GI studies (IBD, Chron's, UC) preferred • Full working proficiency in English • Proficiency in MS Office applications • Ability to plan, multitask and work in a dynamic team environment • Communication, collaboration, and problem-solving skills • Ability to travel up to 80% • Valid driver’s license (if applicable) • Must not require a work visa for employment or continued employment now or anytime in the future

🏖️ Benefits

• Hands-on involvement in every aspect of the study • Career growth opportunities • Work on challenging full-service clinical research projects • Opportunity to grow with a people-focused company

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