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 independently • Provide oversight, leadership, and guidance in clinical trial management and execution • Ensure protocol compliance and quality • Guide, oversee, and provide feedback to the CRA team regarding project scope, SOPs, timelines, and budgets • Review monitoring visit reports and conduct co-monitoring and evaluation visits • Coordinate investigator site visits and cross-functional issue resolution • Assist with study-specific 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 problems, resolutions, protocol deviations, study progress, and enrollment • Review source documents and verify CRF data integrity • Perform quality control and verification of eTMF/TMF documents • Conduct investigational product accountability and review site regulatory binders • Maintain contact with study sites regarding protocol/GCP compliance, patient accrual, and 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 • Assist with CRA training, onboarding, and mentoring • Collaborate on CTMS development and maintenance • Manage conflicting priorities and perform additional assigned duties

🎯 Requirements

• US: BS/BA from an undergraduate program (life sciences or related discipline preferred) • US: 3 years of experience in the pharmaceutical / biotechnology / CRO industry • US: 2 years of clinical monitoring experience with 1 year of management experience • EU: Minimum 2 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry and ability to autonomously manage monitoring activities • Quality-focused; careful, thorough, and detail-oriented • Strong organizational skills; ability to multitask 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 • Strong command of the local language, written and verbal, in the country where monitoring activities are performed • US: Strong command of English, written and verbal • 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 • EU: Graduation in a scientific health field • EU: Adequate English • EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 • US: Permanent authorization to work in the U.S.