Job Description

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 studies that may benefit the local market.

• Ensure compliance with AstraZeneca’s Code of Ethics and with all company policies and procedures relating to people, finance, technology, security, and Safety, Health and Environment (SHE).

• Adhere to all local, national, and regional legislation, as applicable.

• Collaborate with local Medical Science Liaison Officers (MSLs) as directed by LSAD or line manager.

• Responsible for promptly collecting and reporting any adverse events and product quality complaints received from any source. All such cases must be documented accurately and submitted to the designated department within one business day of becoming aware of the information, ensuring compliance with company policies and applicable regulatory requirements.

• Responsible for completing Adverse Event training during initial onboarding and then annually thereafter.

If this sounds appealing, please read on to understand the experience and skills we’re looking for…

ESSENTIAL SKILLS AND EXPERIENCE REQUIRED

• Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification aligned to the knowledge and skills of the role and ensures successful conduct of responsibilities and appropriate interactions with internal and or external stakeholders.

• Minimum of 3 years' proven on-site monitoring experience in clinical research.

• Knowledge of the drug development process and clinical trial lifecycle.

• Experience working with study sites, investigators, and research organizations.

• Understanding of ICH-GCP, clinical trial regulations, and compliance requirements.

• Experience with Risk-Based Quality Management (RbQM) is advantageous.

• Strong communication and relationship-building skills.

• Excellent planning, prioritization, and organizational abilities.

• Critical thinking and problem-solving skills.

• Ability to work independently and collaboratively within cross-functional teams.

• Strong attention to detail and commitment to quality.

• High ethical standards and integrity.

• Learning agility and adaptability in a dynamic environment.

• Fluency in written and spoken English.

• Ability and willingness to travel nationally and internationally as required.

• Valid driver's licence where required by local employment regulations.

Relevant knowledge and ability to fulfil key responsibilities, including but not limited to:
Drug development process, International guidelines ICH-GCP, relevant country regulations, medical knowledge and ability to learn relevant AZ Therapeutic Areas, Clinical Study Management including monitoring, study drug handling and data management.

Why AstraZeneca?

We are proud to have achieved Top Employer certification in South Africa, Kenya, and Nigeria, for 2026. This distinction is a confirmation of our commitment and ability to sustain people, partnerships, and employee engagement and foster an innovative workplace environment. 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. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. 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.

SO, WHAT’S NEXT?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

Click the link to apply no later than 24 July 2026 and we’ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

Our social media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Close Date: 24 July 2026

Date Posted

16-Jul-2026

Closing Date

24-Jul-2026

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.