Senior Clinical Research Associate, French, Dutch

🔥 0 minutes ago

🇧🇪 Belgium – Remote

💵 €58k - €90.5k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 1%

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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

• Independently perform, coordinate and oversee clinical site monitoring services • Assess protocol and regulatory compliance according to company and sponsor processes, ICH/GCP guidelines and local regulations • Serve as the primary liaison between the sponsor/Alimentiv and investigative sites • Execute clinical study plans • Provide guidance and mentoring to CRA I and II • Conduct and document onsite and remote site monitoring, close-out, qualification and initiation visits • Review study data against source documents and resolve or escalate data queries • 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, recruitment milestones, communications and study-system access • Participate in study meetings, investigator meetings, audits and inspections • Mentor CRA I and II; perform CRA assessment and co-monitoring visits • Participate in process improvement and best-practice initiatives

🎯 Requirements

• 4–6 years of related experience • (Honors) Bachelor’s degree • Fluent in written and verbal English • Equivalent combination of education and experience may be considered • 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 • 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 • Fluent French and Dutch, as indicated by the job title

🏖️ 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 (internet, VoIP, land line, etc.) • Monthly cell phone stipend of €40 • One-time expense reimbursement of up to €500 to purchase office items such as a scanner/printer, extra monitor, office furniture and supplies • Mileage reimbursement for travel • Remote work arrangement