Senior Clinical Research Associate

🕒 September 24

🌐 Netherlands, Belgium – Remote

🇳🇱 Netherlands – Remote 🇧🇪 Belgium – Remote

💵 €65k - €80k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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 independently • Provide oversight, leadership, and guidance to CRA teams • Ensure adherence to project scope, SOPs, timelines, budgets, protocol, GCP, and regulatory requirements • Review monitoring visit reports and conduct co-monitoring and evaluation visits • Ensure timely investigator site visits • Coordinate cross-functional issue resolution for clinical trial monitoring • Assist with Monitoring Plans, training presentations, ethics documents, and site contract negotiation • Provide monthly billing information to finance • 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 monitoring visit reports covering site issues, resolutions, protocol deviations, study progress, and enrollment • Verify source documents and CRF data integrity • Perform quality control of eTMF/TMF documents and investigational product accountability • Review site regulatory binders • Maintain site contact, assess patient accrual, and respond to sponsor requests • Facilitate adverse event reporting and SAE reconciliation • 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 and train CRAs, including new-hire onboarding • Collaborate on CTMS development and maintenance • Manage conflicting priorities and perform additional assigned duties

🎯 Requirements

• Minimum 3 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry • Ability to autonomously manage monitoring activities • Oncology experience • Availability to travel in Belgium and Netherlands • Quality focused; careful, thorough, and detail-oriented • Strong organizational skills and ability to multi-task in a fast-paced environment • Ability to manage priorities, organize time, and solve problems • Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills • Ability to travel and manage stress • Professional, trustworthy, and disciplined • Ability to problem-solve unstructured or ambiguous challenges • Strong command of the local language, written and verbal, in the country where monitoring activities are performed • Excellent communication and interpersonal skills with customer service orientation • Good computer skills, including clinical trial management systems, clinical trial databases, and electronic data capture • Knowledge of clinical research, ICH GCP, and local regulations • Knowledge of regulatory and ethical requirements • Ability to establish and maintain positive relationships with Sponsor, Site, and Project Team members • Graduation in a scientific health field • Adequate English • Bachelor's degree in Biology, Biotechnology, Life Sciences, Pharmacy, or related scientific health field

🏖️ Benefits

• Remote work • Regular employment contract

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