
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
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.
⢠Coordinate site identification, feasibility assessments, and investigator selection activities ⢠Conduct site qualification, initiation, routine monitoring, and close-out visits according to study monitoring plans ⢠Complete monitoring reports accurately and within established timelines ⢠Ensure investigator sites comply with protocols, ICH-GCP guidelines, Health Canada regulations, and study procedures ⢠Review source documentation and perform source data verification ⢠Support regulatory submissions and essential document collection ⢠Assist with site contracts and budgets, including tracking site payments and documentation ⢠Train and support investigators and site personnel on protocols, investigational products, and study processes ⢠Maintain essential study documents and reconcile TMF and Investigator Site File documentation ⢠Coordinate investigational products and study supplies ⢠Maintain study information in CTMS and other tracking tools ⢠Support patient recruitment and retention initiatives ⢠Identify, communicate, and escalate study risks, issues, and quality concerns ⢠Build relationships with investigators, site staff, and cross-functional project teams
⢠Fluent French and English ⢠Degree in Life Sciences, Nursing, Pharmacy, or a related healthcare discipline ⢠Minimum of 3 years of independent clinical monitoring experience within a CRO, biotechnology, pharmaceutical, or academic research environment ⢠Proven experience managing clinical trial sites across the full study lifecycle ⢠Hands-on oncology clinical trial monitoring experience and experience working with oncology investigator sites ⢠Strong working knowledge of ICH-GCP guidelines and Canadian regulatory requirements ⢠Demonstrated ability to work independently in a remote contractor environment ⢠Excellent organizational, problem-solving, and risk management skills ⢠Strong interpersonal, communication, and stakeholder management abilities ⢠Ability to adapt to changing priorities and work effectively in a fast-paced environment ⢠Willingness and ability to travel to investigator sites as required
⢠Flexible contractor engagement with an approximate 0.5 FTE commitment ⢠Opportunity to work on innovative oncology clinical trials ⢠Exposure to leading biotech and pharmaceutical sponsors ⢠Collaboration with highly experienced global clinical research teams ⢠Meaningful work that contributes to advancing treatment options for patients worldwide ⢠Opportunity to work with a company recognised for its expertise in nephrology, oncology, and cardiometabolic research
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