Clinical Research Associate

🔥 7 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $110k - $130k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 1%

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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 • Provide oversight, leadership, and guidance in clinical-trial management and execution • Ensure protocol compliance and quality • 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 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 monitoring visit reports documenting site problems, resolutions, protocol deviations, study progress, and enrollment • Review and verify source documents and CRF data • Perform quality control and verification of eTMF/TMF documents • Conduct investigational product accountability • Review site regulatory binders • Maintain contact with study sites regarding protocol/GCP compliance, accrual, and sponsor requests • Ensure compliance with ICH GCP, FDA regulations, and 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 • Assist with CRA training and onboarding; mentor CRAs • Collaborate on CTMS development and maintenance • Manage conflicting priorities and deliver commitments

🎯 Requirements

• 2+ years monitoring experience • 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 multi-task and work effectively in a fast-paced environment • Able 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 • Knowledge of clinical research, ICH GCP, and local regulations • Knowledge of regulatory and ethical requirements • Bachelor's degree in Biology, Life Sciences, or equivalent listed education