
201 - 500 employees
Founded 2020
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
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.
🔥 17 hours ago
🗣️🇪🇸 Spanish Required
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201 - 500 employees
Founded 2020
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
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.
• Independently conduct and document onsite and remote site monitoring and close-out visits • Ensure protocol, regulatory, SOP, ICH-GCP, and study-process compliance • Serve as primary liaison between the sponsor/Alimentiv and investigative sites • Review source documents and study-system data for consistency and compliance • Monitor, resolve, and escalate data queries and site issues • Coordinate shipment of investigational products, laboratory supplies, ePROs, and study documents • Train site staff on protocols, study plans, systems, and ICH-GCP • Review ISF and TMF for accuracy, timeliness, and completeness • Act as primary contact for investigational-site questions and issues • Support site activation, qualification, initiation, recruitment, and project milestones • Support regulatory and start-up teams with site documents, localization, and translation • Participate in study meetings, investigator meetings, audits, and inspections • Mentor CRA I and II and perform CRA assessment or co-monitoring visits • Contribute to hiring interviews, process improvements, and best-practice development
• 4–6 years of related experience • (Honors) Bachelor’s degree • Fluent in written and verbal English and Spanish • Thorough knowledge of ICH-GCP and local regulatory requirements • Proficient in EDC systems (e.g., Medidata Rave, Oracle InForm), IRT, eTMF, CTMS, and Microsoft Office Suite • Ability to travel up to 40–60%, depending on project assignment and geographic location of sites • Strong interpersonal and problem-solving skills; able to work independently and within cross-functional teams • Great communication and organizational skills, detailed orientation and sense of urgency • Holder of a valid driver’s license • Equivalent combination of education and experience may be considered
• Home-based work arrangement • Regular travel required • Potential professional mentoring and development through CRA I and II mentorship • Participation in process improvement initiatives and development of best practices
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