Senior Clinical Research Associate

🔥 2 hours ago

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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 • Be involved in study startup (if applicable) • Perform CRF review, source document verification and query resolution • Be responsible for site communication and management • Supervise study activities, timelines, and schedules on the country level • Be a point of contact for in-house support services and vendors • Be involved in quality control, such as compliance monitoring and reports review • Participate in feasibility research • Support regulatory team in preparing documents for study submissions

🎯 Requirements

• College/University degree in Life Sciences or an equivalent combination of education, training & experience • Independent on-site monitoring experience in the USA (5 years minimum) • 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) is preferred. • Full working proficiency in English • Proficiency in MS Office applications • Ability to plan, multitask and work in a dynamic team environment • Ability to travel up to 80% • Valid driver’s license (if applicable)

🏖️ Benefits

• health insurance • retirement plans • paid time off • flexible work arrangements • professional development