Clinical Research Associate

Additional Locations: France-Voisins le Bretonneux; France-Île-de-France

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: France

Preferred area: Paris area

About This Role

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 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.

In all actions the CRA demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

The CRA monitors progress of clinical studies at the site level to verify that the rights and well being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements.

The CRA also provides support in enrollment, follow-up and closure of clinical trial activities through collaboration with Trial Operations, Regulatory Affairs and the Contract & Budget teams, and with divisional and regional clinical teams.

Key Responsibilities

• Source Verification: Conducts a comparison of data recorded on Case Report Forms against source documents, verifies Informed Consent Forms for accuracy and completeness, reviews regulatory documents and device accountability records.
• Communications: Ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos and general correspondence. Escalates serious issues as per company’s escalation process when appropriate.
• Training: Ensures all site personnel is appropriately trained and prepared to conduct the clinical study in accordance with protocol and applicable regulations. Monitors and maintains site personnel list, qualification and training records.
• Compliance: Ensures compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal SOPs/WIs, policies & procedures. Ensures any identified site non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview. Support internal quality audits and regulatory inspections, as required.
• Event Reporting: Ensures that all reportable events are identified, clearly documented and reported per protocol and per applicable requirements and regulations.
• Collaboration: Participates in study-specific meetings, teleconferences and training. Collaborates with cross-functional team members and study sites throughout all study phases.
• Documentation: Manages study request/collection of relevant (i.e. regulatory documents) investigator/site documentation.
• Study maintenance: Updates and maintains study-specific monitoring milestones in Clinical Trial Management Systems.

Required Qualifications

• Bachelor’s Degree, or an equivalent combination of experience and education
• Fluency in French and English (written and spoken)
• Research Coordinator or Clinical Research Associate experience
• Experience in Clinical Field Monitoring
• Good organizational skills
• Strong communication & presentation skills
• Comfortable interacting with clinical research site personnel
• Ability to work in team
• Ability to multi-task: support several studies and/or personnel simultaneously
• Ability to work in a very fast-paced and dynamic environment
• Comfortable travelling up to 80% of time, mainly in France but not excluding short travels abroad
• Driving license

Preferred Qualifications

• Experience working with Clinical Trial Management and Electronic Data Capture systems
• Medical Device experience
• 3rd spoken language (Spanish/German/Dutch, intermediate level)

Requisition ID: 599797

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!