Senior Clinical Research Associate

🔥 16 minutes ago

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Alimentiv

WebsiteLinkedInAll Job Openings

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.

📋 Description

• Manage, deliver and/or perform full clinical site monitoring services for one or more projects, potentially involving multiple services, complex studies, and multinational projects • Design and oversee project monitoring services, including training, site/patient recruitment, site data/document management, project site budgets, and regulatory filings aligned with SOPs, study guidelines, and GCP best practices • Act as the primary liaison between CRAs and the project team as Lead CRA • Participate in developing project plans, protocols, CRFs, communications, monitoring forms, documents, and tools • Conduct and document onsite and remote site monitoring, close-out, qualification, and initiation visits • Review study data against source documents, resolve or escalate data queries, and ensure compliance with study requirements • Coordinate shipment and delivery 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; request missing site documents • Serve as primary contact for investigational-site questions and issues • Track site issues, action items, and protocol deviations through resolution • Coordinate site communications and provide project, regulatory, and study updates • Support site activation, regulatory document review/localization/translation, and study start-up • Optimize patient recruitment and help sites meet recruitment milestones • Participate in audits, inspections, study meetings, teleconferences, and Investigator meetings • Mentor and support CRA I and II • Perform CRA assessment visits, co-monitoring visits, and visit sign-off processes • Participate in CRA interviews, process improvement initiatives, and best-practice development

🎯 Requirements

• Minimum of a college diploma/degree • 4–6 years of related experience • Ability to regularly travel to clinical sites • Proficiency with EDC systems such as Medidata Rave and Oracle InForm • Proficiency with IRT, eTMF, CTMS, and Microsoft Office Suite • Ability to travel up to 40–60%, depending on project assignment and site geography • Strong interpersonal and problem-solving skills • Ability to work independently and within cross-functional teams • Strong communication and organizational skills • Detailed orientation and sense of urgency • Fluency in English and French

🏖️ Benefits

• Full-time, Permanent • Bonus • Home-based work arrangement