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Associate Researcher

Sotalent

An opportunity is available for a Research Associate to support the monitoring and management of clinical research sites. The role is responsible for ensuring clinical studies are conducted in accordance with study protocols, regulatory requirements, and applicable industry guidelines while maintaining high standards of data quality and site compliance. Key Responsibilities Conduct site monitoring activities, including site selection, initiation, routine monitoring, and close-out visits in accordance with study protocols and regulatory requirements. Support study sites with participant recruitment planning and monitor recruitment progress against project timelines. Deliver protocol and study-related training to assigned sites and maintain regular communication to address study progress and operational issues. Evaluate site compliance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements, escalating quality concerns where appropriate. Track study milestones, including regulatory submissions, approvals, participant enrolment, case report form (CRF) completion, and data query resolution. Ensure essential study documentation is complete, accurate, and maintained within the Trial Master File (TMF) and Investigator Site File (ISF). Prepare monitoring reports, follow-up correspondence, and other required study documentation. Collaborate with cross-functional study teams to support successful project delivery. Assist with site-level recruitment planning and tracking where required. Support site financial administration and invoice processing in accordance with study agreements, where applicable. Requirements Bachelor's degree in a scientific, life sciences, or healthcare-related discipline preferred, or an equivalent combination of education and experience. Previous clinical research monitoring experience or completion of a Clinical Research Associate (CRA) training programme may be required. Working knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and clinical research regulations. Understanding of clinical study protocols and therapeutic areas. Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint. Strong written and verbal communication skills. Excellent organisational, analytical, and problem-solving abilities. Effective time management and attention to detail. Ability to build and maintain productive working relationships with internal teams, clinical sites, and external stakeholders. #J-18808-Ljbffr Sotalent

Vacancy posted 1 day ago
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