Descripción de la oferta
We are seeking an experienced Clinical Research Associate (CRA) to support monitoring and site management activities across multiple studies. The role involves close collaboration with study teams, sites, and cross-functional stakeholders, with a strong commitment to patient safety, data integrity, and product quality. Key Responsibilities * Conduct on-site and remote monitoring activities, including visit preparation, follow-up, site contact, and report writing. * Support site start-up activities, including EC/CA submissions, contract negotiation, and essential document collection. * Attend study meetings and collaborate with cross-functional teams and sites throughout all study phases. * Provide support in audit preparation and responses. * Schedule and conduct monitoring visits according to the study monitoring plan. * Review informed consents, regulatory files, and site study documentation, ensuring compliance with study protocols and applicable regulations (ISO 14155:2020, ICH-GCP). * Identify and report compliance issues, working with project management to ensure timely resolution. * Ensure monitoring reports are finalized within 28 days of each site visit. * Provide interim site management services, including remote monitoring, as required. Qualifications * Prior CRA experience (on-site and remote) within medical devices or pharma (ISO 14155:2020, ICH-GCP). * Strong knowledge of EC/CA submission processes and regulatory requirements. * Excellent organizational and communication skills, with ability to collaborate across cross-functional teams. * Proactive, detail-oriented, and committed to patient safety and quality standards. ✨ This opportunity offers involvement in multiple excluively sponsor studies, exposure to a wide range of clinical operations, and the chance to work in a dynamic, high-quality environment. #J-18808-Ljbffr
