Contribute to identifying and assessing potential investigators to build a high-performing site network aligned with protocol needs and patient access.
lead start-up and regulatory maintenance including Site Qualification Visits; collection, preparation, review and tracking of documents; and submissions to EC/IRB and Regulatory Authorities for study start-up and throughout the study.
Train, support and advise Investigators and site staff on study-specific requirements and Risk Based Quality Management principles; confirm completion and documentation of required training, including ICH-GCP; keep sites inspection-ready at all times.
Actively participate in Local Study Team meetings and contribute to National Investigators meetings as applicable; share recruitment and site performance insights to drive data-informed decisions and actions.
Initiate, monitor and close study sites in line with AstraZeneca Procedural Documents and the study-specific Monitoring Plan; perform remote and onsite visits and remote data checks; collaborate with LSAD on visit timing and type when required.
Perform Source Data Review, Case Report Form review and Source Data Verification per the Monitoring Plan; conduct regular Site Quality Risk Assessments and adapt monitoring intensity accordingly; ensure timely data query resolution and partner with data management to drive robust data quality.
Ensure accurate and timely reporting of Serious Adverse Events and follow-ups; escalate systematic or serious quality issues, data privacy breaches and CSP or ICH-GCP compliance issues per local processes; ensure compliance with the Code of Ethics, company policies (including SHE) and local/national/regional legislation.
Manage study supplies, drug supplies and drug accountability at sites; prepare study drug for destruction where applicable.
Update CTMS and other systems within required timelines; prepare and finalize monitoring visit reports and follow-up letters in line with SOPs; ensure timely collection and upload of essential documents into the eTMF and support regular QC checks; ensure site documents and communications are ready for archiving and completion of the local eTMF.
Prepare for and collaborate during audits and regulatory inspections with LSAD and CQAD; assist sites in maintaining an inspection-ready ISF.
Provide feedback on research-related information including site and investigator insights and competing studies; collaborate with local MSLs as directed by LSAD or line manager.
Drive site performance by proactively identifying issues, resolving them promptly and escalating appropriately; with tenure and experience, take on additional responsibilities associated with LSAD to broaden your impact.
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