Lead Clinical Research Associate

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $110k - $130k / year

⏰ Full Time

🟠 Senior

🔬 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

• Provides guidance, oversight, and feedback to the field CRA team • Ensures quality of data is in line with clinical standards • Monitors performance of CRAs on a continuous basis • Performs CRA mentoring and oversight of CRA activities • Coordinates with appropriate cross-functional departments • Assists in development of study-specific Clinical Monitoring Plans • Supports CRA hiring through initial screening • Conducts review of CRA time and expenses • Prepares consistently accurate and timely monitoring visit reports • Ensures integrity of CRF data through meticulous source document review • Conducts investigational product accountability • Maintains regular contact with study sites

🎯 Requirements

• US: BS/BA from an undergraduate program (life sciences or related discipline preferred) • US: 4 years of experience in the pharmaceutical / biotechnology / CRO industry • 2 years’ experience in clinical monitoring with 1 year of management experience • EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 • EU: Graduation in a scientific/health field • EU: Extensive experience in clinical monitoring • Excellent knowledge of clinical research, ICH GCP, regulatory, ethical and local regulations

🏖️ Benefits

• Professional development • Global travel • Flexible work programs