Clinical Research Associate
hace 4 semanas
As a Clinical Research Associate - Site Start-Up Specialist at Boston Scientific, you will play a critical role in supporting the Global Clinical Operations Center of Excellence. Your primary responsibility will be to conduct site start-up activities for clinical trials, ensuring compliance with regulatory requirements and company policies. This includes preparing and submitting regulatory documents, negotiating informed consent forms, and collaborating with clinical sites to ensure a smooth start-up process.
Key Responsibilities:
* Coordinate site start-up activities for clinical trials, including preparation and submission of regulatory documents
* Negotiate informed consent forms with clinical sites
* Collaborate with clinical sites to ensure a smooth start-up process
* Ensure compliance with regulatory requirements and company policies
Requirements:
* 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
* Strong communication and presentation skills
Preferred Qualifications:
* Research Coordinator or In-House Clinical Research Associate / Clinical Research Associate / Study Start-up specialist experience
* Experience working with Ethic Committee's
* Experience working with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems / eTMF
About Boston Scientific:
Boston Scientific is a global leader in medical science, committed to solving the challenges that matter most. Our mission is to advance science for life, transforming 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. If you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you.
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