Clinical Research Associate – IQVIA Biotech (Homebased in Paris)

The Clinical Research Associate role at IQVIA Biotech involves site monitoring, study management, and collaboration within clinical trials, primarily for biotech and pharmaceutical projects. The position is home-based in Paris, requiring experience in clinical research and monitoring.

Location: Courbevoie, France

Responsibilities

• Perform site monitoring visits in accordance with GCP and ICH guidelines.
• Work with sites to adapt, drive, and track subject recruitment plans.
• Administer protocol and study training to sites.
• Evaluate the quality and integrity of study site practices.
• Manage the progress of assigned studies, including regulatory submissions, recruitment, and data management.
• Ensure proper documentation and filing in the Trial Master File.
• Create and maintain documentation regarding site management and monitoring findings.
• Collaborate with study team members for project execution.
• Support development of project subject recruitment plans.
• Support site financial management as applicable.

Requirements

• Background in Life Science, Nursing, Pharmacy, or a medical degree.
• Previous experience as a Study Coordinator.
• Minimum of 1 year of monitoring experience, ideally in oncology.
• Bachelor's Degree in a scientific discipline or healthcare (or equivalent experience).
• Completion of CRA training or prior monitoring experience (preferred).
• Knowledge of GCP and ICH guidelines.
• Good therapeutic and protocol knowledge.
• Proficiency in Microsoft Word, Excel, PowerPoint, and use of laptops and mobile devices.
• Good written and verbal communication skills in English.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish effective working relationships.