Senior Clinical Research Associate

🕒 July 6

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Alira Health

501 - 1000 employees

⚕️ Healthcare Insurance

💰 $58M Venture Round on 2023-01

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.

📋 Description

• Conduct site monitoring responsibilities for clinical trials • giving oversight, leadership, and guidance in managing clinical trials • Ensure compliance and quality of trials while collaborating closely with teams • Review monitoring visit reports and conduct visits as needed • Coordinate with departments for negotiation/issue resolution related to monitoring • Manage study budget and act as referent for the sponsor • Perform visits both remotely and onsite, ensuring documentation of monitoring visits • Prepare accurate and timely monitoring visit reports • Maintain compliance with ICH GCP guidelines, FDA regulations, and SOPs • Facilitate adverse event reporting and manage conflicting priorities • Participate in internal and client/sponsor meetings

🎯 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 • 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 15Nov2011. • EU: Graduation in a scientific health field. • EU: Adequate English

🏖️ Benefits

• Professional development • Global travel • Flexible work programs

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