Clinical Research Associate, Oncology

AstraZeneca - Wilmington, DE

Full-time - Mid Level

Wilmington, DE

Chemical Manufacturing

About the position

As a Clinical Research Associate (CRA) in Oncology at AstraZeneca, you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. This position is field-based, and you will have local responsibility for the delivery of studies at allocated centers, actively participating in local study teams. You will work closely with other Monitors and the Local Study Delivery Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. Your responsibilities will include the preparation, initiation, monitoring, and closure of an agreed number of centers in clinical studies, adhering to AstraZeneca's Procedural Documents, international guidelines such as ICH and GCP, as well as relevant local regulations. You will be expected to deliver according to the commitments in the individual trials, ensuring compliance and quality throughout the process. In this role, you will leverage your expertise in Oncology therapeutic areas, applying your knowledge of international guidelines and local regulations to ensure the successful execution of clinical trials. You will be responsible for managing multiple tasks with conflicting deadlines, demonstrating strong analytical and problem-solving skills. Your ability to communicate effectively, both verbally and in writing, will be crucial as you negotiate and collaborate with various stakeholders. Additionally, you will need to be adaptable and flexible, responding quickly to shifting demands and opportunities in a dynamic work environment. This position requires a commitment to quality and efficiency, as you will be championing more effective methods and processes to deliver high-quality clinical trials within budget and time constraints.

Responsibilities

• Prepare, initiate, monitor, and close clinical studies at allocated centers.
• Collaborate with other Monitors and the Local Study Delivery Team to ensure quality and quantity commitments are met.
• Ensure compliance with AstraZeneca's Procedural Documents, ICH, GCP, and local regulations.
• Manage multiple tasks with conflicting deadlines while maintaining quality standards.
• Champion efficient and effective methods for delivering clinical trials.

Requirements

• Bachelor's degree required, preferably in Life Science field.
• Minimum 2 years of CRA experience in Oncology therapeutic experience required.
• Fluent knowledge of spoken and written English.
• Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
• Good knowledge of relevant local regulations.
• Good medical knowledge in 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.
• Ability to travel as required, 50-70%.

Nice-to-haves

• Experience with remote collaboration tools and techniques.
• Familiarity with electronic data capture systems.
• Knowledge of additional therapeutic areas beyond Oncology.

Benefits

• Opportunity to make a substantial difference in patients' lives.
• Access to industry-leading skills and diverse perspectives.
• Inclusive and diverse work environment.