AstraZeneca is a global, science-driven biopharmaceutical company dedicated to discovering, developing, and commercializing innovative medicines to treat some of the world’s most serious diseases. With a strong focus on patient care, AstraZeneca operates in over 100 countries, delivering life-changing therapies in oncology, cardiovascular, respiratory, and other key therapeutic areas.
At AstraZeneca, we foster an inclusive and collaborative work environment where employees are encouraged to push scientific boundaries and make a real difference in healthcare.
Job Description: Clinical Research Associate (CRA)
Key Responsibilities:
- Site Management: Oversee study site activities, ensuring compliance with ICH-GCP, local regulations, and AstraZeneca protocols.
- Monitoring & Compliance: Conduct remote and on-site monitoring visits, ensuring data integrity and patient safety.
- Regulatory & Start-Up: Assist in site qualification, regulatory submissions, and essential document collection.
- Risk-Based Quality Management (RbQM): Implement risk assessment strategies to optimize study quality.
- Collaboration: Work closely with investigators, study teams, and data management to ensure smooth trial execution.
- Documentation & Reporting: Maintain trial master files (eTMF), prepare monitoring reports, and ensure timely resolution of data queries.
- Inspection Readiness: Ensure sites are always prepared for audits and regulatory inspections.
Skills & Experience Required:
Essential:
- Bachelor’s degree in life sciences or related field.
- Strong knowledge of ICH-GCP, clinical trial monitoring, and regulatory requirements.
- Experience in site management, data review, and risk-based monitoring.
- Excellent communication, negotiation, and problem-solving skills.
- Ability to travel nationally/internationally as needed.
Desirable:
- Prior experience in risk-based monitoring (RBM) and remote monitoring tools.
- Familiarity with eTMF, CTMS, and electronic data capture (EDC) systems.
- Strong analytical skills and ability to manage multiple tasks efficiently.
Why Join AstraZeneca?
- Innovative Work Environment: Contribute to groundbreaking research in a leading global pharmaceutical company.
- Career Growth: Opportunities for professional development and advancement.
- Inclusive Culture: A diverse and collaborative workplace that values every employee’s contribution.
- Work-Life Balance: Flexible policies supporting employee well-being.
