Alimentiv
Alimentiv is a specialty contract research organization focused on gastrointestinal (GI) and liver diseases. With over 30 years of experience, Alimentiv offers a comprehensive range of clinical research and imaging services, including clinical trial management, site management, regulatory affairs, and precision medicine. The company is at the forefront of medical research and development, providing state-of-the-art imaging solutions and actionable biomarker insights. Alimentiv supports the development of GI compounds and is active in more than 60 countries, working with a network of medical and operational experts to accelerate clinical trials and patient recruitment.
Clinical Trials Design • Planning • Safety Management • Custom Services • Study Management
Regulatory Coordinator
January 8
Alimentiv
Alimentiv is a specialty contract research organization focused on gastrointestinal (GI) and liver diseases. With over 30 years of experience, Alimentiv offers a comprehensive range of clinical research and imaging services, including clinical trial management, site management, regulatory affairs, and precision medicine. The company is at the forefront of medical research and development, providing state-of-the-art imaging solutions and actionable biomarker insights. Alimentiv supports the development of GI compounds and is active in more than 60 countries, working with a network of medical and operational experts to accelerate clinical trials and patient recruitment.
Clinical Trials Design • Planning • Safety Management • Custom Services • Study Management
📋 Description
• Assist with and/or complete clinical trial submissions to Regulatory Authorities, Ethics Committees and other review bodies responsible for authorizing the conduct of clinical trials, ensuring compliance to ICH GCP, regional/local requirements. • Submission support throughout the lifecycle of a clinical trial and timely tracking and filing of documents related to submissions and subsequent activities (e.g., approval, acknowledgements, correspondence, requests for information, etc.). • Assist with continuous improvement initiatives within the department
🎯 Requirements
• Minimum of Post-Secondary Certificate +1-3 years of related experience. • Life sciences specialty and/or Regulatory designation is preferred. • Attention to detail. • Flexible and adaptable. • Basic understanding of the regulatory submission requirements for clinical trials (regional-focus). • Basic understanding of ICH-GCP. • Resourceful; i.e., ability to source regulatory requirements in the public domain or the Regulatory Intelligence platforms. • Proficient in Microsoft-based systems: Word, Excel, PowerPoint.
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