AstraZeneca is a global, science-led biopharmaceutical company dedicated to discovering, developing, and commercializing prescription medicines that address some of the world’s most serious diseases. We are more than just one of the world’s leading pharmaceutical companies; we are a place where people can push the boundaries of science and unleash their entrepreneurial spirit.
Job Description:
The Clinical Research Associate (CRA) will play a pivotal role in the local delivery of oncology studies, focusing on recruitment and quality data collection at assigned sites. As a CRA, you will collaborate closely with other CRAs, the Local Study Team, and Local Study Managers to ensure timely and efficient study delivery. You will serve as the primary contact for investigators and site staff, monitoring the study conduct to ensure proper delivery and compliance with AstraZeneca procedures, international guidelines (ICH-GCP), and local regulations.
Key Responsibilities:
- Contribute to the selection of potential investigators.
- Accountable for study start-up and regulatory maintenance, including site qualification visits and document management.
- Train, support, and advise investigators and site staff on study-related matters.
- Ensure sites are inspection-ready and compliant with ICH-GCP training requirements.
- Monitor site performance and drive resolution of study-related issues.
- Perform monitoring visits, source data review, and case report form review.
- Ensure accurate and timely reporting of Serious Adverse Events.
- Assist sites in maintaining inspection-ready documentation.
- Collaborate with local stakeholders for site study delivery.
- Support the implementation of innovative processes and technologies.
Qualifications:
- Bachelor’s degree in a related discipline, preferably in life sciences.
- Excellent knowledge of ICH-GCP guidelines and basic knowledge of GMP/GDP.
- Good understanding of clinical study management and drug development processes.
- Strong attention to detail, with excellent written and verbal communication skills.
- Good collaboration, negotiation, and interpersonal skills.
- Ability to travel nationally/internationally as required.
- Valid driving license.
Why AstraZeneca?
At AstraZeneca, we are committed to creating a great place to work, where you are empowered to push the boundaries of science and grow professionally. Our inclusive culture values diversity, collaboration, and continuous learning. Join us on an exciting journey to pioneer the future of healthcare.
