Clinical Research Associate

Do you have a passion for advancing clinical research and improving patient outcomes through high-quality clinical trial execution? Are you motivated by working with investigators, research sites, and cross-functional teams to deliver innovative medicines to patients? If so, AstraZeneca may be the place for you. ABOUT ASTRAZENECA AstraZeneca is a global, global, science-led, patient-focused Biopharmaceutical business that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca we are dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There is no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth, and development. Our strategic priorities reflect how we are working to deliver our strategy and achieve our Purpose. As a workforce, we are the catalyst for our values: we are entrepreneurial; we do the right thing; we play to win; we put patients first and we follow the science. As a company we appreciate and take great pride in each team member where every person is brought together through shared values, that underpins a shared purpose. There is no better place to feel inspired and energised. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and crafting the patient ecosystem. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Join the fastest-growing pharmaceutical in our markets, set up to fuel further growth. Be part of our shared ambition and pride: our strong heritage, our turnaround story, and early investment and commitment in international markets. There’s no better place to feel inspired and energized. ABOUT OUR CLINICAL TEAM You will join AstraZeneca's BioPharma Clinical Operations team within Site Management & Monitoring, working alongside experienced clinical research professionals dedicated to delivering high-quality clinical trials. The team collaborates closely with investigators, study sites, local study teams, and cross-functional stakeholders to ensure clinical studies are executed efficiently and in compliance with regulatory requirements and Good Clinical Practice (GCP). What You will do The Clinical Research Associate (CRA) will join our BioPharma Clinical Operations team. This role provides an exciting opportunity to contribute directly to the successful delivery of clinical studies while ensuring the highest standards of quality, compliance, patient safety, and data integrity. The Clinical Research Associate (CRA) has local responsibility for delivery of studies at assigned sites and actively participates as a member of the local study team. Working in close collaboration with other CRAs and the Local Study Team or Local Study Associate Director (LSAD), the CRA ensures that study commitments are met efficiently and within required timelines. The CRA role is the primary contact for the study site and has the responsibility for monitoring study conduct and ensuring proper study delivery. The role encompasses the preparation, initiation, monitoring, and closure of allocated clinical study sites, in accordance with AstraZeneca’s procedural documents, international guidelines such as ICH-GCP, and relevant local regulations, ensuring each site delivers on its commitments within individual studies. The CRA role reports to Director Site Management & Monitoring (SMM), to Country Head (CH) or Associate Director, SMM. This position can be based in Johannesburg or Cape Town. Key Responsibilities Become familiar with and perform Therapeutic Area (TA) training including relevant indication and Clinical Study Protocol (CSP) training, as required for the study. Contribute to the selection of potential investigators through the conduct of Site Qualification Visits. In some countries, and as required, is accountable for study start-up and regulatory maintenance. This may include collecting, preparing, reviewing, and tracking documents for the application process, and submitting applications/documents to Ethics Committees (EC)/Institutional Review Boards (IRB) and Regulatory Authorities for both start-up and study duration. Conduct Site initiation visits and throughout the study train, support, and advise investigators and site staff on study-related matters, including principles of Risk-Based Quality Management (RbQM). Confirm that site staff have completed and documented all required training before and throughout the study, ensuring sites remain inspection ready. Actively participate in Local Study Team (LST) meetings and Investigator meetings, guarantee effective and proactive communication with all stakeholders. Contribute to National Investigator meetings, as applicable. Initiate, monitor, and close study sites in accordance with AstraZeneca Procedural Documents, sharing updates on patient recruitment and site progress within the LST. Drive site performance by proactively identifying and ensuring timely resolution of study-related issues, escalating where appropriate. Update the Clinical Trial Management System (CTMS) and other relevant systems with study site data within required timelines. Manage study supplies (including Investigator Study File (ISF)), drug supplies, drug accountability at study sites and prepare study drugs for destruction, where applicable. Perform monitoring visits (both remote and onsite) and remote data checks as specified in the relevant procedural documents and as scheduled in the study-specific Monitoring Plan including, determining the appropriate timing and type of visits in consultation with the LSAD, if needed. Conduct regular Site Quality Risk Assessments (SQRAs) and adjust monitoring intensity accordingly during the study. Collaborate with data management to maintain robust quality of collected study data by ensuring timely resolution of data queries. Ensure accurate and prompt reporting of Serious Adverse Events and subsequent follow-ups. Prepare and finalise monitoring visit reports in CTMS and provide timely feedback and follow-up letters to Principal Investigators, in accordance with required timelines and AstraZeneca procedures. Follow-up outstanding actions with study sites to ensure prompt resolution. Adhere to quality issue processes by escalating serious or systematic quality concerns, data privacy issues, or compliance breaches to Local Management and/or Clinical Quality Associate Director (CQAD), as needed. Assist sites in maintaining an inspection-ready ISF. Prepare for and collaborate on activities associated with audits and regulatory inspections, in liaison with LSAD and CQAD. Collect and upload essential documents into the electronic Trial Master File (eTMF) in accordance with ICH-GCP, AstraZeneca SOPs, and local requirements, and participate in regular QC checks as performed by LSAD or delegate. Ensure all documents under their responsibility are available and prepared for final archiving and completion of the local section of the eTMF. Provide feedback on research-related information, including details about sites, investigators, or competing stu