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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