Senior Clinical Research Associate

🕒 May 9

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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

• 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 • Ensures appropriate and timely investigator site visits • Coordinate with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues • Performs qualification, initiation, interim, and close-out visits both remotely and onsite • Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status • Maintains regular contact with study sites to ensure protocol/GCP compliance • Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs

🎯 Requirements

• BS/BA from an undergraduate program (life sciences or related discipline preferred) • 3 years of experience in the pharmaceutical / biotechnology / CRO industry • 2 years of clinical monitoring experience with 1 year of management experience • Minimum 2 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry in EU • Ability to autonomously manage monitoring activities • Strong command of English, both written and verbal • Strong command of Local language, both written and verbal, in the country where monitoring activities are performed • Professional, trustworthy, and disciplined • Knowledge of clinical research, ICH GCP and local regulations • Knowledge of Regulatory and Ethical requirements

🏖️ Benefits

• Professional development • Global travel • Flexible work programs