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Clinical Research Associate, Senior CRA

🔥 10 minutes ago

🇺🇦 Ukraine – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🗣️🇺🇦 Ukrainian Required

Where this job comes from

Posted on PSI CRO AG's careers page, not through a job board

First seen by Remote Rocketship 10 minutes ago

Logo of PSI CRO AG

PSI CRO AG

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

• Prepare, conduct, and report on all types of monitoring visits, including site selection, initiation, routine monitoring, and close-out visits • Ensure compliance with study protocols, ICH-GCP guidelines, and regulatory requirements • Build and maintain strong relationships with investigators and site staff • Monitor patient recruitment, study timelines, and site performance • Perform source data verification, follow up on data queries, and manage site-level risks • Oversee investigational product accountability, trial supplies, and essential study documentation • Maintain Investigator Site Files (ISF) and support Trial Master File (TMF) reconciliation • Deliver study-specific training to investigators and site staff • Support regulatory submissions, audit preparation, and resolution of audit findings

🎯 Requirements

• MD, PharmD or MSc • 1+ year of independent on-site monitoring experience in Ukraine • Experience in all types of monitoring visits in Phase II and/or III • Experience in Oncology/Ulcerative Colitis/Antibiotics trials is a plus • Full working proficiency in English and Ukrainian • 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

🏖️ Benefits

• Opportunity to further develop skills • Widen therapeutic area experience • Become an expert in clinical research

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