Senior Clinical Research Associate – FSP

• Independently monitor clinical studies through all stages and phases, with a focus on oncology.
• Take local responsibility for study delivery at allocated sites and act as the main site contact.
• Prepare, initiate, monitor, and close assigned clinical study sites.
• Contribute to investigator selection and national investigator meetings.
• Support study start-up and regulatory maintenance, including site qualification visits and EC/IRB and regulatory submissions where required.
• Train, support, and advise investigators and site staff on study-related matters and RbQM principles.
• Participate in Local Study Team meetings and support LST coordination or document preparation.
• Confirm completion and documentation of required site staff training, including ICH-GCP training.
• Drive site performance, identify study issues, ensure timely resolution, and escalate appropriately.
• Update CTMS and other systems with site data within required timelines.
• Manage study supplies, drug supplies, drug accountability, and drug destruction preparation where applicable.
• Conduct remote and onsite monitoring visits and remote data checks according to the Monitoring Plan.
• Perform Source Data Review, CRF review, and Source Data Verification.
• Conduct Site Quality Risk Assessments and adapt monitoring intensity.
• Ensure timely data query resolution and collaborate with data management on study data quality.
• Ensure accurate and timely Serious Adverse Event reporting and follow-up.
• Prepare and finalize monitoring visit reports and provide feedback to Principal Investigators.
• Follow up on outstanding site actions and escalate systematic or serious quality and compliance issues.
• Assist sites with inspection-ready ISFs and support audits and regulatory inspections.
• Ensure timely collection and uploading of essential documents to the eTMF and support QC checks.
• Ensure study documents are ready for final archiving and completion of the local eTMF.
• Provide useful research-related intelligence about sites, investigators, and competing studies for the local market.
• Ensure compliance with AstraZeneca ethics, policies, procedures, and applicable legislation.
• Collaborate with local MSLs as directed.

• Minimum 3–5 years' experience as a monitor
• Ability to work independently and monitor all stages of a study across different phases
• Special therapeutic expertise in oncology
• Ability to take on LST tasks and support LST coordination or document preparation as required
• Ability to travel internationally as required
• Valid driving license
• Knowledge and application of ICH-GCP, AZ Procedural Documents, SOPs, and relevant local regulations
• Ability to train, support, and advise investigators and site staff
• Ability to ensure site inspection readiness and required training documentation
• Ability to perform monitoring visits, remote data checks, SDR, CRF review, and SDV
• Ability to manage study supplies, drug supplies, and drug accountability
• Ability to resolve data queries and ensure timely Serious Adverse Event reporting
• Ability to prepare monitoring visit reports and maintain CTMS/eTMF documentation
• Ability to identify, escalate, and resolve quality, compliance, and data privacy issues
• Ability to collaborate with Local Study Teams, data management, MSLs, LSAD, CQAD, and regulatory stakeholders

• Fully remote work mode
• Standard Monday–Friday work schedule