Senior Clinical Research Associate

🔥 0 minutes ago

🇷🇴 Romania – Remote

⏱ Part Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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 the management and execution of clinical trials • Ensure protocol compliance, quality, adherence to SOPs, timelines, and budget requirements • Review monitoring visit reports and conduct co-monitoring and evaluation visits • Ensure timely investigator site visits • Coordinate cross-functional departments to resolve clinical trial monitoring issues • Assist with Monitoring Plans, training presentations, ethics documentation, and site contract negotiation • Provide monthly billing information to the finance team • 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 covering site problems, resolutions, protocol deviations, study progress, and enrollment • Verify source documents and ensure CRF data integrity • Perform quality control and verification of eTMF/TMF documents • Conduct investigational product accountability and review site regulatory binders • Maintain regular contact with study sites regarding protocol/GCP compliance, patient accrual, and 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 in-house CRAs/CTC and data management • Identify site issues and develop problem-solving strategies • Prepare study sites for audits • Mentor CRAs and assist with CRA onboarding and training • Collaborate on the development and maintenance of the Clinical Trial Management System (CTMS) • Manage conflicting priorities and perform additional assigned duties

🎯 Requirements

• Minimum 3 years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO industry • Ability to autonomously manage monitoring activities • Availability to travel all over Romania • Oncology experience • Fluent in Romanian and English; any other language is a plus • Strong command of the local language, both written and verbal, in the country where monitoring activities are performed • Graduation in a scientific health field • Adequate English • Quality-focused, 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 and manage stress • Professional, trustworthy, and disciplined • Ability to solve unstructured or ambiguous challenges • 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 • Bachelor of Science in Biology, Biotechnology, Life Sciences, or Pharmacy

🏖️ Benefits

• Remote work arrangement • Part-time schedule • Freelance/contingency workforce engagement