Boston Scientific Clinical Research Associate 

Belgium, Flemish Brabant 

497403194

About this role:

Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, the CRA conductsclinical 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 forCompetent Authority (CA) submissions and approvalsand other site start-up support activities, as applicable.

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.
• Experience in study submissions to the Ethics Committee.
• Fluency (written and spoken), in French, English, and Dutch.
• 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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.