AstraZeneca is a global, science-driven biopharmaceutical company committed to transforming the lives of patients through innovative medicines. With a strong focus on oncology, cardiovascular, renal, respiratory, and rare diseases, AstraZeneca pioneers cutting-edge research to address some of the world’s most serious health challenges.
Operating in over 100 countries, AstraZeneca fosters a culture of collaboration, diversity, and lifelong learning. The company is dedicated to sustainability and ethical practices, ensuring a positive impact on patients and society.
Job Description: Clinical Research Associate (Oncology)
Key Responsibilities:
- Site Management: Contribute to investigator selection, conduct site qualification visits, and ensure regulatory compliance.
- Study Monitoring: Perform remote and on-site monitoring visits, ensuring adherence to ICH-GCP, AZ procedures, and local regulations.
- Training & Compliance: Train site staff on study protocols, maintain inspection-ready documentation, and ensure proper trial conduct.
- Data Quality: Conduct source data verification (SDV), case report form (CRF) reviews, and ensure timely data entry and query resolution.
- Risk Management: Implement Risk-Based Quality Management (RbQM) principles to optimize study performance.
- Regulatory Submissions: Assist in ethics committee (EC) and regulatory authority submissions, where applicable.
- Safety Reporting: Ensure accurate and timely reporting of adverse events (AEs) and serious adverse events (SAEs).
- Collaboration: Work closely with Local Study Teams (LST), investigators, and internal stakeholders to meet study timelines.
Qualifications & Experience:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field.
- Prior experience as a Clinical Research Associate (CRA) in oncology trials is preferred.
- Strong knowledge of ICH-GCP, clinical trial regulations, and monitoring practices.
- Excellent communication, problem-solving, and organizational skills.
- Proficiency in electronic data capture (EDC) and clinical trial management systems (CTMS).
Why Join AstraZeneca?
- Innovative Environment: Work on groundbreaking oncology research with a global impact.
- Career Growth: Access to continuous learning, mentorship, and leadership opportunities.
- Inclusive Culture: A diverse and collaborative workplace that values every voice.
- Work-Life Balance: Flexible policies supporting employee well-being.
