ppWe are seeking an experienced bClinical Research Associate (CRA) /b 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. /p h3Key Responsibilities /h3 ul liConduct on-site and remote bmonitoring activities /b, including visit preparation, follow-up, site contact, and report writing. /li liSupport bsite start-up activities /b, including EC/CA submissions, contract negotiation, and essential document collection. /li liAttend bstudy meetings /b and collaborate with cross-functional teams and sites throughout all study phases. /li liProvide bsupport in audit preparation and responses /b. /li liSchedule and conduct monitoring visits according to the study monitoring plan. /li liReview binformed consents, regulatory files, and site study documentation /b, ensuring compliance with study protocols and applicable regulations (ISO 14155:2020, ICH-GCP).



/li liIdentify and report compliance issues, working with project management to ensure timely resolution. /li liEnsure monitoring reports are finalized within 28 days of each site visit. /li liProvide interim site management services, including remote monitoring, as required. /li /ul h3Qualifications /h3 ul liPrior CRA experience (on-site and remote) within medical devices or pharma (ISO 14155:2020, ICH-GCP). /li liStrong knowledge of EC/CA submission processes and regulatory requirements. /li liExcellent organizational and communication skills, with ability to collaborate across cross-functional teams. /li liProactive, detail-oriented, and committed to patient safety and quality standards. /li /ul p✨ This opportunity offers involvement in bmultiple excluively sponsor studies /b, exposure to a wide range of clinical operations, and the chance to work in a dynamic, high-quality environment. /p /p #J-18808-Ljbffr

📌 Clinical Research Associate -remote- (Madrid)
🏢 Oxford Global Resources
📍 Madrid