Senior Clinical Research Associate

🔥 33 minutes ago

🌐 Germany, Austria – Remote

🇩🇪 Germany – Remote 🇦🇹 Austria – Remote

💵 €70k - €80k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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 independent site monitoring responsibilities for clinical trials • Provide oversight, leadership, and guidance to CRA teams on scope, SOPs, timelines, budgets, compliance, and quality • Review monitoring visit reports and conduct co-monitoring and evaluation visits • Ensure timely investigator site visits and coordinate cross-functional issue resolution • Assist with monitoring plans, training presentations, ethics documentation, and site contract negotiations • Perform qualification, initiation, interim, and close-out visits remotely and onsite • Prepare accurate monitoring visit reports covering site issues, resolutions, protocol deviations, study progress, and enrollment • Verify source documents and CRF data integrity • Perform quality control of eTMF/TMF documents and investigational product accountability • Review regulatory binders and maintain contact with study sites regarding protocol and GCP compliance • 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, develop problem-solving strategies, and support audit preparation • Mentor CRAs and assist with CRA onboarding and training • Collaborate on the development and maintenance of the CTMS • Manage conflicting priorities and perform additional assigned duties

🎯 Requirements

• Minimum 4 years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO industry • Ability to autonomously manage monitoring activities • Availability to travel in Germany and Austria • Oncology experience required • Strong command of the local language, written and verbal, in the country where monitoring activities are performed • Adequate English • Graduation in a scientific health field • Bachelor of Science in Biology, Biotechnology, Life Sciences, or Pharmacy • Knowledge of clinical research, ICH GCP, local regulations, regulatory and ethical requirements • Good computer skills, including clinical trial management systems, clinical trial databases, and electronic data capture • Strong organizational, analytical, negotiation, leadership, meeting management, and cross-functional team skills • Ability to travel, manage stress, prioritize, organize time, and solve problems • Professional, trustworthy, disciplined, detail-oriented, and quality-focused • Excellent communication and interpersonal skills • Ability to establish and maintain positive relationships with sponsors, sites, and project team members

🏖️ Benefits

• Remote work arrangement • Regular employment contract • Referral opportunity mentioned