Clinical Research Associate

🕒 September 3

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $50k - $70k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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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

• Manage and support clinical sites from site approval through close-out • Develop study documents and tools, including ICF templates and site binder contents • Support sites with IRB approval, submission materials, and site-specific ICFs • Respond to regulatory board requests for protocol and ICF clarification • Ensure required regulatory documents and approvals are in place before investigational product shipment • Collect, file, and routinely review regulatory documents at sites and in the TMF • Analyze site performance and protocol adherence problems, identify solutions, and provide ongoing site training • Communicate with study sites regarding protocol/GCP compliance and subject accrual rates • Conduct remote review of eCRF data • Collaborate with field CRAs and data management to resolve discrepant-data queries • Assist with investigative site recruitment • Comply with ICH GCP guidelines, FDA regulations, and company SOPs • Participate in internal, client/sponsor, scientific, and other required meetings • Manage conflicting priorities and deliver commitments • Perform additional assigned duties

🎯 Requirements

• BS/BA from an undergraduate program or equivalent experience • 1-2 years of experience in clinical research • Proven ability to be careful, thorough, and detail-oriented • Strong organizational skills and ability to multi-task in a fast-paced environment • Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills • Ability to problem-solve unstructured or ambiguous challenges • Strong command of English, written and verbal • Excellent communication and interpersonal skills with customer service orientation • Proficient with MS Office Suite, particularly Word and Excel • Permanent authorization to work in the U.S.

🏖️ Benefits

• Remote work with limited travel, supporting collaboration across physical walls and time zones