Senior Clinical Research Associate

🔥 0 minutes ago

🇧🇪 Belgium – Remote

⏱ Part Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 11%

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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 • Provide oversight, leadership and guidance in the management and execution of clinical trials • Ensure protocol compliance and quality • Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed • Ensure appropriate and 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 documentation 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 and timely monitoring visit reports • Review source documents and verify CRF data integrity • Perform quality control and verification of eTMF/TMF documents • Conduct investigational product accountability • Review site regulatory binders • Maintain contact with study sites to ensure protocol/GCP compliance and assess patient accrual • 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 CRAs/CTC and data management • Identify site issues and develop problem-solving strategies • Conduct audit preparation at study sites • Assist with CRA training and onboarding and perform CRA mentoring • Collaborate on development and maintenance of the CTMS • Manage conflicting priorities and perform additional assigned duties

🎯 Requirements

• Minimum 2 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry for EU roles • Ability to autonomously manage monitoring activities • Strong command of the local language, both written and verbal, in the country where monitoring activities are performed • Adequate English • Graduation in a scientific health field • 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 • Strong organizational, analytical, negotiation, meeting management, cross-functional team and leadership skills • Ability to manage priorities, organize time and solve problems • For EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15 Nov 2011

🏖️ Benefits

• Professional development • Global travel • Flexible work programs