Senior Clinical Research Associate

🔥 0 minutes ago

🌐 Netherlands, Belgium – Remote

🇳🇱 Netherlands – Remote 🇧🇪 Belgium – Remote

💵 €60k - €80k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 1%

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Alira Health

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 $58M Venture Round on 2023-01

Healthcare • Manufacturing • Healthcare Insurance

Alira Health is a global consulting firm that partners with life sciences companies to develop innovative solutions in healthcare. The company specializes in a wide range of services including research and clinical development, regulatory compliance, and management consulting. Alira Health focuses on patient engagement, market access, and providing real-world solutions to improve patient outcomes. They are committed to environmental sustainability and actively participate in community involvement and ESG initiatives. Alira Health also provides technology solutions with a focus on improving life sciences research through empathy and scientific excellence.

📋 Description

• Conduct site monitoring responsibilities for clinical trials in the Netherlands and Belgium • Provide oversight, leadership, and guidance in the management and execution of clinical trials • Collaborate with clinical monitoring directors, lead CRAs, in-house CRAs, CRAs, and project managers • Ensure protocol compliance, quality, adherence to SOPs, timelines, and budget requirements • Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed • Ensure timely investigator site visits • Coordinate cross-functional departments to resolve clinical trial monitoring issues • Assist with study-specific monitoring plans and training presentations • Assist with ethics-document collection and site contract negotiation • Provide monthly billing information to the finance team • Manage study budgets and act as sponsor referent for stand-alone projects • Perform qualification, initiation, interim, and close-out visits remotely and onsite • Prepare accurate and timely monitoring visit reports • Verify source documents and ensure CRF data integrity • Perform quality control and document verification for eTMF/TMF • Conduct investigational product accountability and review regulatory binders • Maintain contact with study sites, assess patient accrual, and respond to sponsor requests • Ensure compliance with ICH GCP, FDA regulations, and company/sponsor SOPs • Facilitate adverse-event reporting and reconcile SAE reports with source documentation and CRFs • Resolve discrepant data queries with in-house CRAs/CTC and data management • Identify site issues and develop problem-solving strategies • Prepare study sites for audits • Mentor CRAs and assist with CRA training and onboarding • Collaborate on the development and maintenance of the CTMS • Manage conflicting priorities and perform additional assigned duties

🎯 Requirements

• BS/BA from an undergraduate program in life sciences or related discipline preferred (US) • Minimum 2 years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO industry (EU) • Ability to autonomously manage monitoring activities (EU) • Strong command of the local language, written and verbal, in the country where monitoring activities are performed (Dutch and English) • Adequate English (EU) • Ability to travel • Knowledge of clinical research, ICH GCP, and local regulations • Knowledge of regulatory and ethical requirements • Good computer skills, including clinical trial management systems, clinical trial databases, and electronic data capture • Ability to establish and maintain positive relationships with sponsors, sites, and project team members • Graduation in a scientific health field (EU) • Strong organizational, analytical, negotiation, meeting management, cross-functional team, leadership, and problem-solving skills

🏖️ Benefits

• Professional development • Global travel • Flexible work programs