Senior Clinical Research Associate

đŸ”„ 2 minutes ago

đŸ‡«đŸ‡· France – Remote

⏳ Contract/Temporary

🟠 Senior

đŸ§Ș Clinical Research

đŸ‘» Ghost score 10%

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Logo of TFS HealthScience - Contract Research Organization

TFS HealthScience - Contract Research Organization

501 - 1000 employees

Founded 2007

đŸ’Œ Consulting

đŸ„ 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

‱ Function operationally as a member of a Project Team ‱ Initiate, monitor on-site and remotely, and close out clinical study sites ‱ Monitor clinical trials according to company and sponsor SOPs, GCP/ICH guidelines, and regulatory requirements ‱ Perform monitoring activities to assess subject safety, data integrity, and quality ‱ Verify informed consent procedures and protocol compliance ‱ Review electronic or paper CRFs and subject source documentation ‱ Verify management and accountability of Investigational Product ‱ Prepare Monitoring Visit Reports, document findings and corrective/preventive actions, update tracking systems, and escalate issues ‱ Provide sites with identified issues and required action items ‱ Deliver site documents to eTMF or paper TMF and verify Investigator Site File maintenance ‱ Participate in audit and inspection preparation and follow-up ‱ Order, ship, and reconcile clinical investigative supplies when applicable ‱ Update CTMS and project systems with accurate site-level information ‱ Work dedicated to one global pharmaceutical or biotechnology sponsor

🎯 Requirements

‱ Bachelor’s Degree, preferably in life science or nursing; or equivalent ‱ At least 3 years of oncology monitoring experience ‱ Minimum 1 year in Phase I/II oncology studies ‱ Strong GCP/ICH knowledge ‱ Fluency in English ‱ Ability to work in a fast-paced environment with changing priorities ‱ Ability to work independently and in a team matrix organization ‱ Strong written and verbal communication skills ‱ Excellent organizational skills ‱ Technology savvy and good software and computer skills ‱ Self-awareness, resolute, flexibility, proactivity, collaborative mindset, analytic approach, and attention to detail ‱ Ability and willingness to travel up to 60-80%

đŸ–ïž Benefits

‱ Opportunities for personal and professional growth ‱ Rewarding work environment ‱ Collaboration-focused team culture ‱ Quality-focused culture ‱ Opportunity to make a difference in patients' lives ‱ Flexible clinical development and strategic resourcing solutions

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