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hace 2 meses
We are seeking a highly skilled Clinical Research Associate to join our Global Clinical Operations team. As a Clinical Research Associate, you will play a critical role in supporting the start-up and management of clinical trials across various regions.
Key responsibilities:- Conduct site start-up activities, including ethics committee submissions and approvals, site informed consent form customizations and negotiations, and essential regulatory document collection.
- Collaborate with regulatory affairs for competent authority submissions and approvals and other site start-up support activities.
- Provide support in enrollment, follow-up, and closure of clinical trial activities.
- Manage multiple sets of essential regulatory documents across several studies and division portfolios.
- Develop and foster clinical research site relationships to become a subject matter expert in the site start-up regulatory process.
- Bachelor's degree or equivalent combination of experience and education.
- Experience in study submissions to the Ethics Committee (Spain or Italy).
- Fluency in English, Italian, and Spanish.
- Ability to multi-task and work in a fast-paced environment.
- Clear, concise communication and presentation skills.
- Research coordinator or in-house clinical research associate/study start-up specialist experience.
- Experience working with ethics committees.
- Experience working with clinical trial management systems and clinical document control systems/eTMF.
Boston Scientific is a leader in medical science for over 40 years, committed to solving the challenges that matter most. We are united by a deep caring for human life and are dedicated to advancing science for life. Our mission is to transform lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
