CRA II, French Speaking
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Job Description
Clinical Research Associate monitoring sites, regulatory submissions, and trial documents for Emerald Clinical Trials. Supporting global clinical research across renal, cardiometabolic, and oncology therapies.
Responsibilities:
- Coordinate investigator and trial-site identification, feasibility assessment, and selection
- Complete monitoring activities according to the Monitoring Plan
- Prepare monitoring visit reports accurately and within predetermined timeframes
- Plan, organize, conduct, and report site evaluation visits
- Prepare and coordinate regulatory packages, importation/exportation requirements, and Ethics Committee package updates
- Negotiate site budgets and coordinate site contract execution
- Track invoicing and ensure timely site payments
- Plan, organize, and conduct site initiation visits
- Develop and maintain monitoring tools and project-specific documents
- Train and motivate investigators and site personnel on protocols, investigational products, and trial requirements
- Collect, review, approve, and code essential trial-site documents for Trial Master File filing
- Reconcile in-house Trial Master File and Investigator Site File contents
- Coordinate distribution, tracking, handling, and destruction of investigational products and trial supplies
- Maintain trial information in the clinical trial management system and tracking/reporting tools
- Support strategies to improve recruitment efforts
Requirements:
- Qualifications in a related science or health care discipline
- 2–5 years of experience in on-site monitoring and site management within an academic, CRO, or pharmaceutical environment
- Practical knowledge of ICH-GCP guidelines and global and local ethical and regulatory research requirements
- Competence in ethical and participant safety considerations, site start-up management, site conduct management, risk management, quality management, supply management, scientific concepts and clinical research design, and issue escalation management
- Competence in negotiation and conflict resolution, critical thinking, problem-solving, decision making, and strategic thinking
- Solid interpersonal communication and presentation skills
- Ability to work autonomously and within a multidisciplinary team with varied stakeholders
- Flexibility and adaptability to changing organizational priorities and ambiguous environments
- Ability and willingness to travel
- Must be fluent in French
Benefits:
- Competitive compensation package
- Hybrid or remote working arrangements, depending on location and role
- Career growth and learning opportunities
- Access to a global network of scientific leaders
- Employee wellbeing programs promoting work-life balance, health, and team connection
- Global engagement surveys
- Recognition programs
- Team-building events
- Exposure to diverse international projects and clients
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