
501 - 1000 employees
Founded 2000
đĽ Healthcare
đź Consulting
đŚ Logistics
Healthcare ⢠Consulting ⢠Logistics
Emerald Clinical is a leading global clinical research organization (CRO) founded in the AsiaâPacific region that provides endâtoâend clinical trial services to biopharmaceutical, medical device, and diagnostic companies. With about 25 years of experience and a team of 800+ operating across 40+ locations worldwide, Emerald Clinical manages trials across all phases including registration and postâmarketing studies, and offers clinical operations, project management, and trial staffing support. The company emphasizes scientific expertise, operational excellence, and global reach to support drug and device development.
đĽ 0 minutes ago
đ¨đŚ Canada â Remote
đľ $60k - $90k / year
â° Full Time
đ˘ Junior
đĄ Mid-level
đ§Ş Clinical Research
đť Ghost score 0%
đŁď¸đŤđˇ French Required
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501 - 1000 employees
Founded 2000
đĽ Healthcare
đź Consulting
đŚ Logistics
Healthcare ⢠Consulting ⢠Logistics
Emerald Clinical is a leading global clinical research organization (CRO) founded in the AsiaâPacific region that provides endâtoâend clinical trial services to biopharmaceutical, medical device, and diagnostic companies. With about 25 years of experience and a team of 800+ operating across 40+ locations worldwide, Emerald Clinical manages trials across all phases including registration and postâmarketing studies, and offers clinical operations, project management, and trial staffing support. The company emphasizes scientific expertise, operational excellence, and global reach to support drug and device development.
⢠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
⢠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
⢠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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đ¨đŚ Canada â Remote
đľ $74.7k - $124.5k / year
đ° $1G Post-IPO Debt on 2023-05
â° Full Time
đ˘ Junior
đĄ Mid-level
đ§Ş Clinical Research
đŁď¸đŤđˇ French Required
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