Clinical Research Associate

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Logo of TFS HealthScience - Contract Research Organization

TFS HealthScience - Contract Research Organization

501 - 1000 employees

Founded 2007

🧬 Biotechnology

💊 Pharmaceuticals

⚕ Healthcare Insurance

Biotechnology ‱ Pharmaceuticals ‱ Healthcare Insurance

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

‱ Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures, GCP and ICH guidelines, and applicable regulatory requirements. ‱ Perform all required monitoring activities at study sites to ensure subject safety, data integrity, and quality. ‱ Verify the protection of study participants through informed consent procedures and protocol compliance in accordance with regulatory requirements. ‱ Review CRFs (electronic or paper) and subject source documentation for validity, completeness, and accuracy. ‱ Verify proper management and accountability of Investigational Product. ‱ Prepare timely monitoring visit reports, document findings and follow-up actions, update required tracking systems, and escalate issues as appropriate. ‱ Ensure site documentation is maintained appropriately, support eTMF and ISF compliance, and update CTMS and other required project systems with accurate site information.

🎯 Requirements

‱ Bachelor's Degree, preferably in Life Sciences, Nursing, or equivalent. ‱ Minimum 1 year of relevant clinical research experience or relevant academic background related to clinical trials or clinical development activities. ‱ Understanding of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements. ‱ Strong written and verbal communication skills with fluency in English. ‱ Excellent organizational skills and ability to work independently as well as within a matrix team environment.

đŸ–ïž Benefits

‱ Competitive compensation ‱ Comprehensive benefits ‱ Opportunity for personal and professional growth

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