Senior Clinical Research Associate

🔥 48 minutes ago

🇮🇹 Italy – Remote

💵 €45k - €60k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 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

• Conduct site monitoring responsibilities independently for clinical trials • Provide oversight, leadership, and guidance to CRA teams • Ensure protocol compliance, quality, adherence to SOPs, timelines, and budgets • Review monitoring visit reports and conduct co-monitoring and evaluation visits • Coordinate investigator site visits and resolve clinical trial monitoring issues • Assist with monitoring plans, training presentations, ethics documents, and site contract negotiation • Manage study budgets for stand-alone projects and act as sponsor referent • Perform qualification, initiation, interim, and close-out visits remotely and onsite • Prepare accurate and timely monitoring visit reports • Review source documents and verify CRF data integrity • Perform quality control and verification of eTMF/TMF documents • Conduct investigational product accountability and review site regulatory binders • Maintain contact with study sites, assess patient accrual, and respond to sponsor requests • Ensure compliance with ICH GCP guidelines, FDA regulations, and company/sponsor SOPs • Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs • Resolve discrepant data queries with CRAs/CTC and data management • Identify site issues and develop problem-solving strategies • Conduct audit preparation at study sites • Participate in internal, client/sponsor, scientific, and other meetings • Assist with CRA training, mentor CRAs, and collaborate on CTMS development and maintenance • Manage conflicting priorities and perform additional assigned duties

🎯 Requirements

• Minimum 4 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry • Ability to autonomously manage monitoring activities • Availability to travel in Italy • Oncology experience required • Strong command of the local language, both written and verbal, in the country where monitoring activities are performed • Adequate English • Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 • Graduation in a scientific health field • Bachelor of Science in Biology, Biotechnology, Life Sciences, or Pharmacy • Quality-focused, careful, thorough, and detail-oriented • Strong organizational, analytical, negotiation, meeting management, cross-functional team, and leadership skills • Ability to multitask, manage priorities, organize time, solve problems, manage stress, and handle ambiguous challenges • Professional, trustworthy, and disciplined • 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, local regulations, regulatory and ethical requirements • Ability to establish and maintain positive relationships with sponsors, sites, and project team members

🏖️ Benefits

• Global, collaborative team environment • Opportunities for leadership, mentoring, and professional development through CRA new-hire training and onboarding • Regular, flexible remote and onsite work for clinical trial visits