Clinical Research Associate

Role overview

AstraZeneca is expanding its Site Management and Monitoring teams in Oncology and Cell Therapy and has multiple openings for Clinical Research Associates. These are 12-month contract roles based in Sydney.

In this role, you will help deliver high-quality, patient-focused clinical trials that support advances in oncology and other key therapeutic areas. The position calls for someone who can guide site activation, oversee monitoring activities using a risk-based approach, and protect both patient safety and data quality.

You will work closely with investigators and site teams, help prepare studies for inspections, and contribute to faster, more efficient trial startup and execution.

Key responsibilities

• Assess and select sites and investigators, develop strong working relationships, and support activation, enrolment, and ongoing site performance.
• Manage ethics committee/IRB and health authority submissions, secure approvals, and keep essential study documents complete and inspection-ready.
• Educate and support site staff on ICH-GCP and risk-based quality management, while reinforcing compliance and audit readiness practices.
• Carry out remote and onsite monitoring, including source data review, source data verification, and case report form review; handle data queries; and adjust monitoring effort according to study risk.
• Track and report serious adverse events promptly and address quality issues in line with company procedures.
• Keep CTMS and eTMF records accurate, oversee study drug accountability, and provide timely monitoring reports and follow-up communication.

Required qualifications

• Bachelor’s degree in life sciences or a related discipline, or equivalent practical experience.
• Good understanding of drug development, ICH-GCP, and relevant local regulations.
• Background in site selection, startup, and both remote and onsite monitoring, with strong attention to documentation.
• Experience using CTMS and eTMF systems, managing data queries, and reviewing SDR/SDV/CRF documentation.
• Strong communication, stakeholder management, and problem-solving abilities, with the ability to work independently and in cross-functional teams.
• Willingness to travel for site visits and fluency in business-level written and spoken English.

Preferred experience

• Exposure to CVRM or Respiratory & Immunology studies, especially across multiple countries.
• Experience using risk-based quality management analytics or dashboards to prioritise monitoring actions and remediation.
• Demonstrated contribution to faster study startup and efficient site activation.
• Confidence working through audits and inspections, with experience preparing sites for readiness.
• Comfort using remote monitoring tools, eSource/ePRO, and data-driven decision-making.
• Ability to communicate in the local language in addition to English.

About AstraZeneca

AstraZeneca aims to be a great place to work, where people are encouraged to push scientific boundaries and bring an entrepreneurial mindset. The company promotes an inclusive culture built on diversity, collaboration, learning, growth, and development, and is focused on shaping the future of healthcare.

Application information

Applicants are asked to submit a resume and a cover letter describing the skills and experience relevant to the position.

Additional information

This posting includes a date listed as 26-June-2026 and a closing date of 16-July-2026.

AstraZeneca Australia has been recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency and as a Gold Tier Employer within the Australian Workplace Equality Index. The company highlights its commitment to a flexible, diverse, and inclusive workplace.

If any part of the recruitment process needs to be adjusted to improve accessibility, candidates are invited to let the company know through the provided accommodation request form.

AstraZeneca also states that it welcomes applications from all qualified candidates and complies with applicable non-discrimination, work authorisation, and employment eligibility verification requirements.