CRA II, French Speaking

This is a fully remote position, open to applicants in Canada.

📋 Description

• Oversee the identification and selection of investigators and trial sites, including feasibility assessments.

• Execute monitoring activities in accordance with the established Monitoring Plan.

• Accurately prepare monitoring visit reports within specified timeframes.

• Plan, organize, execute, and document site evaluation visits.

• Prepare and coordinate regulatory packages, including import/export requirements and updates for the Ethics Committee package.

• Negotiate site budgets and facilitate the execution of site contracts.

• Monitor invoicing and ensure prompt payments to sites.

• Plan, organize, and conduct site initiation visits.

• Develop and maintain monitoring tools and project-specific documentation.

• Provide training and motivation to investigators and site personnel regarding protocols, investigational products, and trial requirements.

• Collect, review, approve, and code essential trial-site documents for filing in the Trial Master File.

• Reconcile contents between the in-house Trial Master File and the Investigator Site File.

• Manage the distribution, tracking, handling, and disposal of investigational products and trial supplies.

• Maintain trial information within the clinical trial management system and associated tracking/reporting tools.

• Assist in developing strategies to enhance recruitment efforts.

⛳️ Requirements

• Degree in a relevant science or healthcare discipline.

• 2–5 years of experience in on-site monitoring and site management within an academic institution, CRO, or pharmaceutical setting.

• In-depth understanding of ICH-GCP guidelines and both global and local ethical and regulatory research requirements.

• Proficiency in ethical considerations, participant safety, site start-up management, conduct management, risk management, quality management, supply management, scientific concepts, clinical research design, and issue escalation management.

• Skills in negotiation, conflict resolution, critical thinking, problem-solving, decision-making, and strategic planning.

• Strong interpersonal communication and presentation abilities.

• Capacity to work independently and collaboratively within a multidisciplinary team with diverse stakeholders.

• Adaptability and flexibility to shifting organizational priorities and ambiguous environments.

• Willingness and ability to travel.

• Fluency in French is essential.

🏝️ Benefits

• Competitive compensation package.

• Hybrid or remote working options, based on location and role.

• Opportunities for career growth and professional development.

• Access to a global network of scientific experts.

• Employee well-being programs that promote work-life balance, health, and team connection.

• Participation in global engagement surveys.

• Recognition programs.

• Team-building activities.

• Exposure to a variety of international projects and clients.