Senior Clinical Research Associate, French, Dutch Fluency

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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 • Design and oversee project monitoring services, including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings • Independently conduct and document onsite and remote site monitoring, qualification, initiation and close-out visits • Review study data against source documents and resolve or escalate data queries • Coordinate shipment and delivery of investigational products, laboratory supplies, ePROs and study documents • Train site staff on protocols, study plans, systems and ICH-GCP • Act as primary contact and liaison between investigational sites, CRAs and project teams • Oversee study integrity, site compliance, action items and protocol deviations through resolution • Coordinate site communications and support site activation, recruitment milestones and project timelines • Review ISF, TMF and study-related systems for accuracy, timeliness and completeness • Participate in audits, inspections, investigator meetings, study meetings and teleconferences • Mentor CRA I and II and perform assessment, co-monitoring and visit sign-off activities • Assist with CRA interviews and participate in process improvement and best-practice initiatives

🎯 Requirements

• Minimum of a college diploma/degree and 4–6 years of related experience • Strong communication, organizational, interpersonal and problem-solving skills • Strong attention to detail and critical thinking abilities • Ability to regularly travel to clinical sites • Health Sciences, Life Sciences, Pharmacy or Nursing degree preferred, or Sr. CRA and/or ACRP Certification/Designation • Experience with Phase I–IV clinical trials preferred • Thorough knowledge of ICH-GCP and local regulatory requirements • Proficiency with EDC systems such as Medidata Rave and Oracle InForm, IRT, eTMF, CTMS and Microsoft Office Suite • Ability to travel up to 40–60%, depending on project assignment and site geography • Ability to work independently and within cross-functional teams • Fluency in English, Dutch and French required

🏖️ Benefits

• One-time sign-on bonus of €3,000 • Annual Bonus (Short Term Incentive Program) target = 8% of annual salary • Monthly stipend of €157.83 to offset business use of communication costs • Monthly cell phone stipend of €40 • One-time expense reimbursement of up to €500 (local currency) for office items such as a scanner/printer, extra monitor, office furniture and supplies • Mileage reimbursement for travel