Clinical Research Associate

🕒 August 25

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Alira Health

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 $58M Venture Round on 2023-01

Healthcare • Manufacturing • Healthcare Insurance

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 independently • Provide oversight, leadership, and guidance in clinical trial management and execution • Ensure protocol compliance, quality, adherence to SOPs, timelines, and budget requirements • Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed • Ensure timely investigator site visits • Coordinate cross-functional departments to resolve clinical trial monitoring issues • Assist with Monitoring Plans and training presentations • Set up and collect site ethics documents and assist with site contract negotiation • Provide monthly billing information to the finance team • Manage study budgets and act as sponsor referent for stand-alone projects • Perform qualification, initiation, interim, and close-out visits remotely and onsite • Prepare accurate monitoring visit reports documenting site issues, resolutions, protocol deviations, study progress, and enrollment • Review source documents and verify CRF data integrity • Perform quality control and document verification for eTMF/TMF • Conduct investigational product accountability • Review site regulatory binders • Maintain contact with study sites, assess patient accrual, and respond to sponsor requests • Ensure compliance with ICH GCP, FDA regulations, and company/sponsor SOPs • Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs • Resolve discrepant-data queries with in-house CRAs/CTC and data management • Identify site issues and develop problem-solving strategies • Conduct audit preparation at study sites • Train and onboard new CRAs and mentor CRAs • Collaborate on CTMS development and maintenance • Manage conflicting priorities and perform additional assigned duties

🎯 Requirements

• EU: Graduation in a scientific health field • EU (Italy): 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; careful, thorough, and detail-oriented • Strong organizational skills; ability to multi-task and work effectively in a fast-paced environment • Ability to manage priorities, organize time, and solve problems • Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills • Ability to travel • Ability to manage stress • Professional, trustworthy, and disciplined • Ability to problem-solve unstructured or ambiguous challenges • Strong command of the local language, written and verbal, in the country where monitoring activities are performed • Excellent communication and interpersonal skills with customer service orientation • Good computer skills, including clinical trial management systems, clinical trial databases, and electronic data capture • Self-starter able to thrive in a collaborative, less structured team environment • Knowledge of clinical research, ICH GCP, and local regulations • Knowledge of regulatory and ethical requirements • EU: Adequate English • Bachelor's degree in Biology or Life Sciences

🏖️ Benefits

• Remote work arrangement • Global team collaboration across time zones