Boston Scientific Clinical Research Associate 

Belgium, Flemish Brabant 

302381898

Belgium-Diegem; France-Voisins le Bretonneux; France-Île-de-France; Germany-Düsseldorf; Italy-Milan; Netherlands-Kerkrade; Netherlands-Kerkrade; Netherlands-Maastricht; Poland-Warsaw; Spain-Madrid; United Kingdom-Hemel Hempstead

Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, the CRA conducts
clinical trial site start-up activitiesrelated 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.

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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)
• 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 coordinator, divisional clinical study leads and/or other stakeholders when appropriate.
• Ensure compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal SOPs/WI, policies & procedures.

Minimum Qualifications

• Bachelor’s Degree, or an equivalent combination of experience and education.
• 4-5 years experience in a CRA role
• Experience in study submissions to the Ethics Committee.
• Fluency (written and spoken)Franch, Dutch Mandatory and English. Any additional languauge is a plus.
• 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 Ethic Committee’s.
• Experience working with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems / eTMF.