Freelance Senior Clinical Research Associate

🔥 0 minutes ago

🇮🇹 Italy – Remote

⏳ Contract/Temporary

🟠 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

• Prepare, conduct, and report on site selection, initiation, routine monitoring, and close-out visits • Ensure compliance with study protocols, ICH-GCP guidelines, and regulatory requirements • Build and maintain 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 • Provide guidance and mentoring to less experienced Clinical Research Associates • Act as the main point of communication between clinical trial sites and project teams • Ensure the rights, safety, and well-being of trial participants

🎯 Requirements

• Degree in Life Sciences or a related field, or an equivalent combination of education, training, and experience • Minimum 3 years of independent on-site monitoring experience in Italy, ideally across multiple clinical trials • Experience conducting all types of monitoring visits in Phase I, II, and/or III clinical trials • Good command of English, both written and spoken • Experience supporting oncology studies is an advantage • Good knowledge of ICH-GCP guidelines and clinical trial regulations • Proficiency in Microsoft Office applications • Strong organizational, communication, and problem-solving skills • Ability to work independently and collaboratively in an international team • Valid driver's license and willingness to travel to clinical trial sites

🏖️ Benefits

• Further development of skills • Opportunity to widen therapeutic area experience • Opportunity to become an expert in clinical research

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