Clinical Research Associate

hace 4 días

Madrid, Madrid, España Boston Scientific Gruppe A tiempo completo

About the Role

The Clinical Research Associate - Regulatory Expert supports the Global Clinical Operations Centre 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 behaviours 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 Clinical Research Associate - Regulatory Expert 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 Clinical Research Associate - Regulatory Expert also provides support in enrolment, follow-up, and closure of clinical trial activities.

This role offers weekly hybrid working and can be based from any BSC hub location across Europe.

Your Responsibilities

• 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 Forms (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

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