In-House Clinical Research Associate With Spanish And Italian

hace 1 mes


Madrid, España Boston Scientific A tiempo completo

.Ubicación:Madrid, Madrid provinciaDescripción completa del empleo:Work mode: HybridOnsite Location(s): Madrid, M, ESAdditional Locations: Spain-Madrid; France-Île-de-France; Germany-Düsseldorf; Italy-Milan; Netherlands-Kerkrade; United Kingdom-Hemel HempsteadDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.In-house Clinical Research Associate with Spanish and ItalianTHIS ROLE CAN BE BASED IN MILAN, MADRID, LONDON, PARIS, DUSSELDORF, WARSAWAbout this role:The In-house Clinical Research Associate (CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO's mission of building a world-class shared clinical technology, process innovation and clinical operations team, in partnership with the company's divisions.Your responsibilities will include:Work independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites.Manage multiple sets of essential regulatory documents across several studies and division portfolios.Partner with clinical sites to support the negotiation and customization of Informed Consent Form (ICF).Develop and foster clinical research site relationships to become a subject matter expert in the site start-up regulatory process across multiple studies.Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives.Manage to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking.Manage and problem solve site start-up challenges that arise to mitigate impact to service level agreement and study goals.Develop, prepare, complete and track required regulatory, ICF and legal documentation.Document clinical research site and investigator readiness for participation across multiple studies.Support internal quality audits, regulatory inspections, as applicable.Update and maintain study-specific startup and close-out trackers.Update and maintain site-specific metrics in Clinical Trial Management Systems, file and maintain site documents in eTMFs.Provide updates to leadership on site start-up activities, investigator readiness, regulatory submission, approval status, etc.Escalate challenges and/or initiate outreach to Principal investigators, clinical research site coordinator, divisional clinical study leads and/or other stakeholders when appropriate



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