Senior Clinical Research Associate

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September 6

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Alira Health

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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.

501 - 1000 employees

⚕️ Healthcare Insurance

💰 $58M Venture Round on 2023-01

📋 Description

• Conduct site monitoring responsibilities for clinical trials both remotely and onsite • Provide oversight, leadership and guidance in management and execution of clinical trials • Review monitoring visit reports, perform co-monitoring and evaluation visits • Ensure appropriate and timely investigator site visits • Coordinate with cross-functional departments to resolve monitoring related issues • Assist in development of Monitoring Plans and training presentations • Assist in set up/collection of site specific ethics documents and site contract negotiation • Provide monthly billing information to finance team • Manage study budget for stand-alone projects and act as referent for sponsor • Perform qualification, initiation, interim and close-out visits • Prepare monitoring visit reports documenting problems, resolutions, deviations, progress and enrollment • Ensure integrity of CRF data through source document review and verification • Perform quality control and verification of documents for eTMF/TMF • Conduct investigational product accountability and review site regulatory binder • Maintain regular contact with study sites to ensure protocol/GCP compliance and assess accrual rates • Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs • Work closely with in-house CRAs/CTC and data management to resolve queries • Conduct audit preparation at study sites and assist in CRA new hire training and onboarding

🎯 Requirements

• BS/BA from an undergraduate program (life sciences or related discipline preferred) • 3 years of experience in the pharmaceutical / biotechnology / CRO industry (US) OR Minimum 2 years of clinical monitoring experience (EU) • 2 year of clinical monitoring experience with 1 year of management experience (US) • Ability to travel • Strong command of English (US) OR Adequate English and strong command of local language where monitoring activities are performed (EU) • US: Permanent authorization to work in the U.S. OR EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 • EU: Graduation in a scientific health field • Knowledge of clinical research, ICH GCP and local regulations • Knowledge of Regulatory and Ethical requirements • Excellent communication and interpersonal skills • Good computer skills, ability to use CTMS, clinical trial databases and EDC • Ability to manage priorities, organize time and solve problems

🏖️ Benefits

• professional development • global travel • flexible work programs