Worldwide Clinical Trials
1001 - 5000 employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.
Regulatory Compliance Specialist
🔥 1 minute ago
🌐 Argentina, Mexico, +1 more countries – Remote
⏰ Full Time
🟢 Junior
🚔 Compliance
🚫👨🎓 No degree required
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Worldwide Clinical Trials
1001 - 5000 employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.
📋 Description
• Receive, review, process, and file essential study documents according to local regulations, internal SOPs, guidelines, and the ED Review Plan • Check completeness and quality of Essential Document packages • Communicate corrective actions and ensure issue resolution before approving ED packages and signing off ED checklists • Maintain relevant tracking tools to provide project teams visibility into ED review progress • Prepare and submit electronic copies of approved site essential documents for Trial Master File filing • Review and approve essential documents using Electronic Document Management Systems • Escalate quality issues promptly to relevant parties • Perform additional duties assigned by the Line Manager
🎯 Requirements
• Advanced written and spoken English • Strong organizational and time management skills • Sound judgment and ability to identify decisions requiring supervisory approval • Ability to handle multiple tasks with exceptional accuracy • Computer literacy in Microsoft Word and Excel • University degree preferred, with Life Science desirable, and 1 year of relevant experience • Alternatively, a combination of education and 1 year of relevant experience
🏖️ Benefits
• Diverse and inclusive work environment • Supportive and cohesive teams • Accessible, hands-on leadership • Equal employment opportunities • Exceptional employee experiences • Opportunity to contribute to improving patients' lives
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