Clinical Research Associate

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $85k - $115k / year

⏰ 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 negotiate and resolve clinical trial monitoring issues • Assist with study-specific Monitoring Plans and training presentations • Assist with ethics document collection and site contract negotiation • Provide monthly billing information to finance • 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 problems, resolutions, protocol deviations, study progress, and enrollment • Review source documents and verify CRF data integrity • Perform quality control and verification of eTMF/TMF documents • Conduct investigational product accountability • Review site regulatory binders • Maintain contact with study sites to ensure protocol/GCP compliance and assess patient accrual • Ensure compliance with ICH GCP, FDA regulations, and company/sponsor SOPs • Participate in internal, client/sponsor, scientific, and other meetings • Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs • Collaborate with in-house CRAs, CTC, and data management to resolve discrepant data queries • Identify site issues and develop problem-solving strategies • Conduct audit preparation at study sites as needed • Collaborate with other CRAs to maintain consistency and teamwork • Assist with CRA new-hire training and onboarding • Mentor CRAs • Collaborate on development and maintenance of the CTMS • Manage conflicting priorities and deliver on commitments • 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; proven ability to be careful, thorough, and detail-oriented • Strong organizational skills and ability to multitask 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 of Science in Biology or Life Sciences

🏖️ Benefits

• Remote work • Regular employment contract