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Freelance Senior CRA

Planet Pharma

About the Role As a Senior CRA, you will take ownership of site monitoring activities across assigned studies, ensuring high-quality execution in line with ICH-GCP, protocol requirements, and applicable regulatory standards . You will play a key role in maintaining data integrity, patient safety, and strong site relationships throughout the study lifecycle. Key Responsibilities Conduct all types of monitoring visits including SIV, routine monitoring, and close-out visits Ensure compliance with protocol, ICH-GCP, and regulatory requirements Perform source data verification (SDV) and resolve data queries in EDC systems Identify, document, and follow up on protocol deviations and quality issues Maintain accurate, high-quality monitoring visit reports and TMF documentation Support site start-up and feasibility activities where required Act as the main point of contact for assigned sites Build and maintain strong relationships with investigators and site staff Escalate issues appropriately to study leadership What We’re Looking For Minimum 5 years’ experience as a Clinical Research Associate Experience in oncology, rare disease, or other complex clinical studies Cell therapy experience is a plus but not required Strong knowledge of ICH-GCP and global clinical trial regulations Proven ability to conduct independent site monitoring across multiple phases (I–III preferred) Strong organisational, communication, and problem-solving skills Comfortable working independently in a global, fast-paced environment Experience with EDC/CTMS systems Fluent in English (additional languages advantageous) What’s on Offer Opportunity to work on innovative and complex global studies Exposure to leading-edge therapeutic areas Collaborative, international study environment Strong focus on quality, compliance, and professional development We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. #J-18808-Ljbffr Planet Pharma

Vacancy posted 5 days ago
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