.Work mode: Remote in CountryOnsite Location(s): Madrid, ES#Boston Scientific - For more than 40 years, Boston Scientific has been the world's leading medical device company dedicated to improving the lives of patients. Every day, we face the key challenges of the healthcare industry with innovative products, a culture of collaboration, and a deep passion for improving human life - making a career at Boston Scientific more than just a job. If you want to be a part of it and follow your vocation, then we should get to know each other.We are looking for a Clinical Research Associate (M/F/d) on a remote workmode-basis for the next possible date. 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 collaboration, accountability, innovation, adaptability, integrity, and caring.Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, the CRA conducts clinical trial site start-up activities related to the preparation and approval of regulatory documents, ensuring they are conducted consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures. Specifically, these activities will include:Ethics Committee (EC) submissions and approvals.Site informed consent form (ICF) customizations & negotiations.Essential regulatory document collection.Collaboration with Regulatory Affairs for Competent Authority (CA) submissions and approvals and other site start-up support activities, as applicable.The CRA also provides support in enrollment, follow-up, and closure of clinical trial activities.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).Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives.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