Clinical Trial Specialist, French Speaking
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Job Description
Clinical Trial Specialist supporting French-speaking site start-up, TMF management, and regulatory submissions for Emerald Clinical Trials, a global clinical research CRO.
Responsibilities:
- Support clinical trial activities as the in-house site start-up and maintenance specialist
- Help ensure clinical trials comply with Federal Regulations, ICH guidelines, project plans, IRB/Ethics Committee requirements, and applicable SOPs and guidelines
- Manage clinical trial feasibility processes with the project team
- Coordinate trial start-up activities, including collection of essential site documents
- Submit materials to central IRBs/Ethics Committees
- Support site staff with local IRB/Ethics Committee submissions and informed consent form changes
- Set up, maintain, review, quality-check, and archive Trial Master Files
- Upload and maintain TMF files and folders in the file-sharing system
- Serve as second reviewer for TMF quality control and potentially lead TMF setup, maintenance, and oversight
- Prepare and participate in audit responses
- Quality-check documents and emails before distribution
- Maintain Clinical Trial Management System data and files/folders
- Support investigator payment data entry, tracking, and submissions
- Work with CRA/CTM/PM during site start-up and serve as a site point of contact where applicable
- Assist with presenting final feasibility results to the project management team and/or sponsor
- Assist sites with preparing, planning, organizing, and collecting essential document packets
- Submit final essential document packets to the sponsor or CTM/PM
Requirements:
- College / University diploma / degree; OR at least 2 years related experience and/or training; OR equivalent combination of education and experience
- Ability to perform general administrative duties as needed or required
- Exposure to medical terminology preferred
- Knowledge of ICH/GCP, ethical, and regulatory requirements preferred
- Must be fluent in French and English
- Knowledge of Federal Regulations, ICH guidelines, IRB/Ethics Committee requirements, and applicable SOPs and guidelines
- Ability to support clinical trial feasibility, site start-up, essential document collection, IRB/Ethics Committee submissions, and informed consent form changes
Benefits:
- Purpose-driven work contributing to clinical trials improving lives
- Hybrid or remote working arrangements, depending on location and role
- Learning opportunities and 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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