Clinical Research Associate, CRA

5 days ago

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AstraZeneca

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Biotechnology • Pharmaceuticals • Science

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines. It primarily works in areas of oncology, cardiovascular, renal & metabolism, and respiratory diseases. With operations in over 100 countries, AstraZeneca is dedicated to scientific research and a commitment to providing effective treatments and improving patient health across a wide array of conditions.

10,000+ employees

Founded 1999

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 Post-IPO Debt on 2023-02

📋 Description

• Monitor clinical studies across various oncology trials and ensure accurate, complete, and timely submission of study data and documents • Prepare high-quality monitoring visit reports and follow-up letters in a timely manner • Confident use of relevant study systems, e.g., WBDC, IVRS, ... and maintenance of the CTMS • Participate in international study team meetings and investigator meetings • Contribute to site selection and assess recruitment potential • Initiate study sites, provide training, support, and guidance to site staff • Continuously monitor recruitment performance, site performance, and data quality; escalate issues to study management • Proactively communicate with the study site and the local study team

🎯 Requirements

• Degree in a natural science or medical field • Prior experience as a Monitor (CRA) in the conduct of clinical studies in the field of cell therapy • Interest in modern monitoring approaches such as Risk-Based Quality Management and Remote Monitoring, and a strong willingness to learn and implement these methods • Excellent knowledge of ICH-GCP for the proper conduct of clinical trials • Familiarity with applicable laws (German Medicines Act - AMG) and regulatory requirements • Good understanding of medical issues • Ability to understand different study and process requirements and set appropriate priorities accordingly • Experience monitoring electronic Case Report Forms (Web-Based Data Capture) and preparing monitoring reports • Independent, effective, and structured organizational skills • Analytical and solution-oriented thinking • Strong team skills and the ability to adapt quickly to changing requirements • Excellent communication skills and very good German and English language skills • Willingness to travel frequently, including overnight stays

🏖️ Benefits

• Individual development opportunities and a focus on lifelong learning • A high level of trust, appreciation, and room for co-creation within a focused and passionate team • Office space in the heart of Hamburg that enables collaborative, flexible, and agile working • A diverse, inclusive, and non-discriminatory work environment committed to the Diversity Charter; differences are not only allowed but actively encouraged, and applications from all qualified candidates are welcome • A sustainable company committed to becoming carbon-negative across the entire value chain by 2030