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Senior Clinical Research Associate - UK - FSP

Parexel
United KingdomremoteEnglish6d ago
continuous improvementgcpsen

When our values align, there's no limit to what we can achieve. At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. About the Role We are seeking an experienced Senior Clinical Research Associate based in the UK, ideally in the South West of England (or at least willing to travel there regularly), to join one of our key sponsors. This role is responsible for the successful delivery of clinical studies at assigned investigator sites, serving as the primary point of contact for site management, monitoring, and study execution activities. As an active member of the local study team, you will work closely with clinical operations colleagues and stakeholders to ensure high quality study delivery, patient safety, regulatory compliance, and operational excellence. This is an opportunity to contribute directly to the advancement of innovative therapies while building your expertise within a world class research environment. Key Responsibilities Lead the preparation, initiation, routine monitoring, and close out of assigned clinical trial sites in accordance with protocol requirements, ICH GCP guidelines, sponsor procedures, and local regulations. Serve as the primary contact for investigative sites, building strong partnerships that support successful study execution and patient recruitment goals. Train, support, and advise investigators and site personnel on study requirements, protocol execution, and Risk Based Quality Management principles. Conduct onsite and remote monitoring visits, source data review, source data verification, and case report form review in accordance with study monitoring plans. Proactively identify, manage, and escalate site and study related issues to ensure timely resolution and continued study progress. Perform site quality risk assessments and adapt monitoring activities as appropriate throughout the study lifecycle. Ensure timely and accurate reporting of serious adverse events, query resolution, and quality study data collection. Maintain accurate and up to date study information within CTMS and other required...

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