Senior Clinical Research Associate – Freelance

🔥 48 minutes ago

🇵🇱 Poland – Remote

⏳ Contract/Temporary

🟠 Senior

🧪 Clinical Research

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.

📋 Description

• Independently manage assigned investigator sites throughout the entire study lifecycle • Conduct feasibility, pre-study, site initiation, routine monitoring, co-monitoring, quality oversight, and close-out visits • Ensure study milestones and site deliverables are achieved according to timelines • Verify source data and ensure accurate completion of Case Report Forms (CRFs) • Review informed consent documentation, regulatory files, essential documents, and investigational product accountability records • Identify, document, and resolve protocol deviations and data discrepancies • Prepare monitoring reports, follow-up communications, and site correspondence • Ensure site personnel are appropriately trained and qualified • Monitor site performance metrics and address compliance or quality issues • Escalate risks and issues while driving timely resolution • Support audit and regulatory inspection readiness activities • Collaborate with project teams, investigators, vendors, and cross-functional stakeholders • Participate in study meetings, training sessions, and project-related activities

🎯 Requirements

• Bachelor's degree in Life Sciences or a related field • Minimum 3–5 years of independent clinical monitoring experience as a CRA or Senior CRA • Minimum 1 year of experience in Ophthalmology clinical trials, including Retinopathy, Age-Related Macular Degeneration (AMD) and/or Diabetic Macular Edema (DME) studies • Strong knowledge of ICH-GCP, clinical trial regulations, and monitoring best practices • Demonstrated experience independently conducting all monitoring visit types • Excellent site management, communication, and problem-solving skills • Ability to travel within Poland as required

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth • Collaborative and innovative work environment

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