Clinical Research Associate Job Openings at AstraZeneca – Apply Online

Clinical Research Associate Job Openings at AstraZeneca – Apply Online

Clinical Research Associate

Locations: India – Bangalore

Time type: Full time

Posted on: Posted Yesterday

Time left to apply: End Date: October 18, 2025 (7 days left to apply)

Job requisition ID: R-236738

Accountabilities for this Clinical Research Associate Job 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: 17-Oct-2025

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