Clinical Research Associate
il y a 6 jours
Drive the future of clinical trials as a CRA supporting a global center of excellence in high‑quality, patient‑focused research. R&D Partners is seeking a Clinical Research Associate (CRA) to support the Global Clinical Operations (GCO) Center of Excellence. This role involves conducting clinical trial activities in alignment with GCO's mission of delivering high-quality data collection, study acceleration, and technology-enabled processes. The CRA will ensure compliance with regulatory requirements, maintain patient safety, and collaborate with cross-functional teams to drive clinical trial success. The ideal candidate will demonstrate collaboration, accountability, innovation, adaptability, integrity, and a commitment to patient safety and product quality. Please note that to be considered for this role you must have the right to work in this location. Responsibilities:Source Verification: Compare Case Report Forms with source documents, verify Informed Consent Forms, review regulatory documents, and manage device accountability records.Communications: Provide clear written communication to clinical sites and project teams through monitoring reports, follow-up letters, and study memos. Escalate serious issues as needed.Training: Ensure site personnel are trained and prepared to conduct clinical studies per protocol and regulations. Maintain site personnel qualification and training records.Compliance: Ensure adherence to regulatory requirements (ICH-GCP, MDR, GDPR) and internal SOPs. Address and escalate non-compliance issues as required. Support internal audits and regulatory inspections.Event Reporting: Identify, document, and report all events per protocol and applicable regulations.Collaboration: Participate in study-specific meetings, teleconferences, and training. Collaborate with cross-functional teams and study sites throughout all study phases.Documentation: Manage study requests and collect relevant regulatory and investigator-site documentation.Study Maintenance: Update and maintain study-specific monitoring milestones in Clinical Trial Management Systems. Key Skills and Requirements:Required Qualifications: Bachelor's Degree or equivalent combination of education and experience.Fluency in French and English (written and spoken).Minimum 3 years of experience in Clinical Field Monitoring.Experience as a Research Coordinator or Clinical Research Associate.Strong organizational, communication, and presentation skills.Ability to multi-task and work in a fast-paced environment.Comfortable traveling up to 80% of the time (mainly in France, with occasional short trips abroad).Valid driver's license and access to a personal car for travel. Preferred Qualifications: Experience with Clinical Trial Management and Electronic Data Capture systems.Medical Device experience in Oncology, Rhythm Management, or Endoscopy.Proficiency in a third language (Spanish preferred, intermediate level). For more information, please contact Elliott Croft. If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page. R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy. By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.r-dpartners.com/privacy-policy/
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