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Clinical Research Associate With Spanish And Italian |
hace 1 mes
.Additional Locations:Spain-Madrid; France-Île-de-France; Germany-Düsseldorf; Italy-Milan; Netherlands-Kerkrade; United Kingdom-Hemel Hempstead Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At 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. Clinical Research Associate with Spanish and Italian THIS ROLE CAN BE BASED IN: MILAN, MADRID, LONDON, PARIS, DUSSELDORF, WARSAW About this role: Work mode: hybrid The 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, through technology enablement, high-touch customer service, study acceleration, and high-quality data collection. Driving principles and behaviors for this role are caring, diversity, global collaboration, high performance, meaningful innovation, and winning spirit. 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 agreements 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
