Clinical Research Associate with French

Additional Locations: Belgium-Diegem; Netherlands-Kerkrade; Netherlands-Kerkrade

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Location: EMEA hub (Belgium, Netherlands)  

About the role:

The In-House 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 collaboration, accountability, innovation, adaptability, integrity and caring.

Key Responsibilities:

• Coordinate and Lead: Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, drive site regulatory submissions and essential document collection for clinical research sites throughout start up, enrollment, follow-up, and closure of clinical trial activities.
• Document Management: Handle multiple sets of essential regulatory documents across several studies.
• Collaborate: Partner with clinical sites to negotiate and customize Informed Consent Forms (ICF). Collaborate cross functionally to achieve business objectives. 
• Relationship Building: Develop and foster relationships with internal customers and clinical research sites to become a subject matter expert in site start-up regulatory processes.
• Problem Solving: Assist clinical research sites with application submission processes and approval tracking to meet target IRB/EC timelines. Problem-solve site start-up challenges to mitigate impact on service level agreements and study goals.
• Prepare and Track: Prepare, complete, and track required regulatory, ICF, and legal documentation.
• Quality Assurance: Document site and investigator readiness for participation across multiple studies.
• Support: Assist with internal quality audits and regulatory inspections.
• Maintain: Keep study-specific startup and close-out trackers updated.
• Update: Maintain site-specific metrics in Clinical Trial Management Systems and electronic Trial Master File (eTMF).
• Communicate: Provide updates to leadership on site start-up activities, investigator readiness, regulatory submission, and approval status.
• Compliance: Ensure adherence to regulatory requirements (ICH/GCP, MDR, GDPR) and internal SOPs/WI, policies, and procedures.

Qualifications:

• Educational Background: Degree in a relevant scientific or healthcare subject.
• Experience: 2/5 years of experience in study submissions to Ethics Committees in France.
• Language Skills: Fluency in French and English; additional languages are beneficial.
• Communication: Strong communication skills and ability to interact with clinical research site personnel.
• Team Player: Ability to work independently and in a team environment.
• Problem-Solving: Strong problem-solving skills and learning agility.

Preferred Qualifications:

• Experience: Previous experience as a Research Coordinator or Clinical Research Associate/Study Start-up Specialist. Experience in study submissions to Ethics Committees in Belgium (French speaking) is valued.
• Technical Skills: Familiarity with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems/eTMF.

What We Offer:

• Innovative Environment: Work in a groundbreaking multinational company with attractive benefits.
• Growth Opportunities: Access to upskilling and mentoring programs.
• Purposeful Mission: Be part of a company with a purposeful mission.
• Stability: Enjoy a permanent position with a hybrid work model.
• Work-Life Balance: Benefit from a hybrid work environment that supports work-life balance.

Requisition ID: 601956

As a leader in medical science for more than 40 years, we are 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. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And 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!