Alira Health
Healthcare Insurance • Consulting
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.
Senior Clinical Research Associate
Job not on LinkedIn
November 18
🗣️🇫🇷 French Required
Alira Health
Healthcare Insurance • Consulting
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.
đź“‹ Description
• Conduct site monitoring responsibilities for clinical trials • Provide oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality • Review monitoring visit reports, conduct co-monitoring and evaluation visits as needed • Ensure appropriate and timely investigator site visits • Coordinate with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues • Assist in development of study-specific Monitoring Plans and training presentations as required • Manage study budget and act as referent for the sponsor • Prepare consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status • Maintain regular contact with study sites to ensure protocol/GCP compliance, assess patient accrual rates, and respond to sponsor requests • Comply with and ensure team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs • Conduct audit preparation at study sites as needed
🎯 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, 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 • US: Permanent authorization to work in the U.S. • EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15 Nov 2011. • EU: Graduation in a scientific health field. • US: Strong command of English, both written and verbal • EU: Strong command of Local language, both written and verbal, in the country where monitoring activities are performed
🏖️ Benefits
• Professional development • Global travel • Flexible work programs
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