Clinical Research Associate

Purpose of the Job

• The Clinical Research Associate (CRA) has local responsibility for the delivery of the oncology studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. 

• The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.

Typical Accountabilities

• Manage assigned clinical trial sites from study start-up through close-out
• Build and maintain effective partnerships with investigators and site staff
• Conduct on-site and remote monitoring activities to ensure protocol and GCP compliance
• Support patient recruitment, data quality, and study delivery objectives
• Identify risks and drive timely issue resolution with study stakeholders
• Maintain study documentation and support inspection readiness 

Functional Capabilities (that are most critical to this position)

• Clinical trial monitoring and site management
• Risk assessment and issue resolution
• Regulatory and GCP compliance
• Stakeholder communication and collaboration

Essential Qualification

• Bachelor’s degree in Life Science, Pharmacy, Nursing, or related field
• Knowledge of ICH-GCP and local clinical trial regulations
• Understanding of clinical development and study management processes
• Strong communication, collaboration, and organizational skills
• Ability to travel as required

Desired skills or requirements

• Experience in oncology clinical trial monitoring or site management
• Strong problem-solving and prioritization skills
• Ability to manage multiple studies and deadlines
• Familiarity with risk-based monitoring approaches
• Adaptability in a dynamic and technology-enabled environment

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