ACCOUNTABILITIES

• Support selection of potential investigators and manage study start-up activities, including regulatory tasks and document submissions.
• Train and guide investigators and site staff, ensuring required training completion and inspection readiness.
• Initiate, monitor, and close study sites in compliance with AstraZeneca procedures and regulatory requirements.
• Oversee site performance, proactively resolve study-related issues, and ensure accurate updates in study systems.
• Manage study supplies and drug accountability at assigned sites.
• Conduct monitoring visits and remote data checks, including Source Data Review and Verification, per study plans.
• Perform regular Site Quality Risk Assessments and adapt monitoring intensity as needed.
• Ensure timely data query resolution and quality of study data, reporting Serious Adverse Events promptly.
• Prepare visit reports, provide feedback to investigators, and follow up on outstanding site actions.
• Escalate quality or compliance concerns, support audits and inspections, and ensure timely document collection and upload.
• Collaborate with study teams and support sites in maintaining inspection-ready documentation and compliance.

ESSENTIAL SKILLS/EXPERIENCE

• Bachelor 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. Sees change as an opportunity to improve performance and add value to the business.
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
• 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 to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

Are you ready to make a significant impact in the field of clinical research? As a Clinical Research Associate (CRA) at AstraZeneca, you’ll play a pivotal role in delivering studies at allocated sites, ensuring timely and efficient achievement of study commitments. You’ll act as the main point of contact with study sites, working closely with other CRAs and the Local Study Team. Your responsibilities will include monitoring study conduct, ensuring compliance with international guidelines and local regulations, and driving the entire process from study preparation and initiation to monitoring and closure. Your expertise will help bring innovative treatments to patients faster and with the highest standards of quality.