Clinical Research Associate

hace 2 semanas

Madrid, Madrid, España Boston Scientific Gruppe A tiempo completo
About this role:

The In-house Clinical Research Associate will support the Global Clinical Operations 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.

Key responsibilities:
  • Conduct 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.
  • 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 agreement 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.
  • Escalate challenges and/or initiate outreach to Principal investigators, clinical research site coordinators, divisional clinical study leads, and/or other stakeholders when appropriate.
Requirements:
  • Bachelor's Degree, or an equivalent combination of experience and education.
  • Experience in study submissions to the Ethics Committee (Spain or Italy).
  • Fluency (written and spoken) in English, Italian, and Spanish.
  • Ability to multi-task: support several studies and/or personnel simultaneously, work in a very fast-paced environment.
  • Ability to work in a team environment and possess clear, concise communication & presentation skills – written and verbal.
  • Must be comfortable interacting with clinical research site personnel via phone, email, and in person.
Preferred qualifications:
  • Research Coordinator or In-House Clinical Research Associate / Clinical Research Associate / Study Start-up specialist experience.
  • Experience working with Ethics Committees.
  • Experience working with clinical trial management systems (e.g., Siebel CTMS, Veeva) 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 – united by a deep caring for human life. Our mission to advance science for life is about 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.

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