Clinical Research Associate

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $85k - $125k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

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Alira Health

WebsiteLinkedInAll Job Openings

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

• Provide guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements. • Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed. • Ensures appropriate and timely investigator site visits. • Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues. • Assists in development of study-specific Monitoring Plans and training presentations as required. • Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits. • Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.

🎯 Requirements

• Graduation in a scientific health field • Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 • Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members • Ability to autonomously manage monitoring activities • Quality focused; Proven ability to be careful, thorough, and detail-oriented • Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment • Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills • Ability to travel • Knowledge of clinical research, ICH GCP and local regulations • Knowledge of Regulatory and Ethical requirements

🏖️ Benefits

• Professional development • Global travel • Flexible work programs • Creative environment