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

• Monitoring of clinical trials across various oncology studies and ensuring correct, complete, and timely submission of study data and documents • Timely preparation of high-quality reports and follow-up letters from monitoring visits • Confident use of relevant study systems, e.g., WBDC, IVRS, etc., and maintenance of the CTMS • Participation in international study team meetings and investigator meetings • Contributing to site selection and assessment of recruitment potential • Initiation of study sites, training, support and guidance of site personnel • Ongoing monitoring of recruitment performance, site performance and quality, with escalation of deficiencies to study management • Proactive communication with study sites and the local study team

🎯 Requirements

• University degree in a scientific or medical field • Prior experience as a monitor in conducting clinical trials in the field of cell therapy • Interest in modern monitoring approaches such as Risk-Based Quality Management and Remote Monitoring • Excellent ICH-GCP knowledge for the proper conduct of clinical trials • Knowledge of relevant legislation (e.g., German Medicines Act - AMG) and regulatory requirements • Good understanding of medical/clinical issues • Understanding of different study and process requirements and ability to set the right priorities accordingly • Experience monitoring electronic Case Report Forms (Web-Based Data Capture) and preparing monitoring reports • Independent, effective, and structured working style • Ability to think analytically and solution-oriented • Strong team skills and the ability to respond quickly to changing requirements • Excellent communication skills and very good German and English language skills • Willingness to travel frequently with overnight stays

🏖️ Benefits

• Individual development opportunities with a focus on lifelong learning • A trusting, appreciative environment and scope to shape your role within a focused and passionate team • Office space in the heart of Hamburg enabling collaborative, flexible and agile working • A diverse, inclusive and non-discriminatory work environment committed to the Diversity Charter • A sustainable company committed to becoming net negative in CO2 across the entire value chain by 2030