Clinical Research Associate

at  Boston Scientific Corporation

Work mode: Hybrid
Onsite Location(s):Diegem, BRU, BE
Additional Locations: Italy-Milan; France-Île-de-France; Germany-Düsseldorf; Netherlands-Kerkrade; Poland-Warsaw; Spain-Madrid; United Kingdom-Hemel Hempstead

ABOUT THIS ROLE:

Work mode: hybrid
The Clinical Research Associate (CRA) supports the Global Clinical Operations (GCO) 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.
Driving principles and behaviors for this role are caring, diversity, global collaboration, high performance, meaningful innovation, winning spirit.

Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, the CRA conducts 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. 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.

The CRA also provides support in enrollment, follow-up, and closure of clinical trial activities.

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.