Clinical Research Associate with French

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. 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. 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.