Clinical Research Associate

Accountabilities for this role include:

• 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, 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 ongoing 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 and regional laws and legislation, as applicable.
• Collaborate with local Medical Science Liaison Officers (MSLs) as directed by LSAD or line manager.

Date Posted

Closing Date

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.