Site Care Partner / senior CRA - sponsor dedicated - Belgium

📋 Description

• • Serve as the primary point of contact for investigative sites in Belgium, building and maintaining strong, collaborative relationships to ensure operational excellence.
• • Lead site start-up activities including site selection, activation, and recruitment planning to ensure timely and compliant study initiation.
• • Verify that informed consent processes are properly performed and documented for all subjects/patients, ensuring adherence to ethical and regulatory standards.
• • Protect subject/patient confidentiality and assess factors impacting subject safety and clinical data integrity, including protocol deviations, violations, and pharmacovigilance concerns.
• • Manage end-to-end site operations from start-up through closeout, ensuring all site-level activities align with project timelines, budgets, and quality objectives.
• • Act as the local/country Subject Matter Expert on regulatory requirements and operational implementation, providing guidance to sites and internal teams.
• • Serve as the operational liaison for site-level inquiries, escalating issues to appropriate team members as needed to resolve challenges efficiently.
• • Prepare for and participate in Investigator Meetings, sponsor face-to-face meetings, and global clinical monitoring/project staff meetings, including representation of sponsor interests when applicable.
• • Ensure sites are audit-ready by providing guidance on compliance standards and supporting preparation for and follow-up of regulatory audits.
• • Monitor and manage site performance against project deliverables, adapting quickly to shifting priorities to meet study goals and timelines.
• • Attend and contribute to clinical training sessions as required by project-specific protocols and sponsor expectations.
• • Maintain strong computer proficiency and actively adopt new technologies to enhance operational efficiency and data management.
• • Travel as required to conduct on-site monitoring visits across Belgium to ensure compliance and site performance.
• • Demonstrate fluency in both Dutch and French to effectively communicate with sites, sponsors, and internal stakeholders across linguistic regions.
• • Apply knowledge of Good Clinical Practice (GCP) and ICH guidelines to ensure all activities meet international regulatory standards.
• • Understand project scope, budgets, and timelines, and align site-level execution with overall clinical team objectives.