Are you ready to make a difference in the world of oncology? As an Oncology Clinical Research Associate (CRA) at AstraZeneca, you will play a pivotal role in the delivery of oncology studies at allocated sites. You will be the main point of contact for investigators and site staff, ensuring that study commitments are met efficiently and effectively. Your responsibilities will include the preparation, initiation, monitoring, and closure of clinical study sites, all while adhering to international guidelines and local regulations. With opportunities for growth and additional responsibilities, this role is perfect for those looking to advance their career in clinical research.
Accountabilities
• Contributes to the selection of potential investigators.
• Accountable for study start-up and regulatory maintenance in some countries.
• Trains, supports, and advises Investigators and site staff in study-related matters.
• Confirms completion of required trainings by site staff.
• Actively participates in Local Study Team meetings.
• Initiates, monitors, and closes study sites in compliance with AZ Procedural Documents.
• Drives performance at the sites and resolves study-related issues.
• Updates CTMS and other systems with data from study sites.
• Manages study supplies and drug accountability at study sites.
• Performs monitoring visits and remote data checks.
• Conducts Source Data Review, Case Report Form review, and Source Data Verification.
• Ensures timely data entry and query resolution.
• Ensures accurate reporting of Serious Adverse Events.
• Prepares monitoring visit reports and provides feedback to Principal Investigator.
• Follows quality issue processes and escalates issues as needed.
• Prepares for audits and regulatory inspections.
• Ensures timely collection/uploading of essential documents into the eTMF.
• Provides feedback on research-related information useful for the local market.
• Ensures compliance with AstraZeneca’s Code of Ethics and local regulations.
• Collaborates with local stakeholders for site study delivery.
• Supports the implementation of innovative processes and technologies.
Essential Skills/Experience
• Bachelors degree in related discipline, preferably in life science, or equivalent qualification.
• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
• Good knowledge of relevant local regulations.
• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
• Basic understanding of the drug development process.
• Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
• Excellent attention to details.
• Good written and verbal communication skills.
• Good collaboration and interpersonal skills.
• Good negotiation skills.
• Ability to travel nationally/internationally as required.
• Valid driving license.
Desirable Skills/Experience
• Ability to work in an environment of remote collaborators.
• Manages change with a positive approach for self, team, and the business.
• Ability to look for and champion more efficient methods/processes of delivering quality clinical trials.
• Good analytical and problem-solving skills.
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
• Familiar with risk-based monitoring approach including remote monitoring.
• Good cultural awareness.
• Ability to understand the impact of technology on projects and develop computer skills.
At AstraZeneca, we are driven by our passion for science and our commitment to transforming the lives of patients living with cancer. Our pioneering spirit leads us to push boundaries, challenge norms, and take smart risks. With one of the broadest Oncology pipelines in the industry, we offer endless opportunities to work with novel drugs and innovative approaches. Our collaborative environment fosters diverse perspectives, empowering everyone to contribute to our mission of eliminating cancer as a cause of death.
Join us in making a meaningful difference—apply today!
Date Posted
27-พ.ย.-2025Closing Date
31-ธ.ค.-2025AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.