Alejandra Rubio Clinical Research Associate

Clinical Research Associate II

ICON Plc

Feb 2023 - Current (3 years 4 months)

Phase III study- Therapeutical Area: Cardiology Coordinated and scheduled protocol-related visits including site selection, initiation, interim monitoring visits. Experience in start up process for ensuring ready to enroll of sites. • Conduct clinical trial in accordance with protocol for nine sites assigned. • Gathered and organized clinical trial documentation to ensure study start up process.

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Clinical Research Associate I

Vaxtrials

Jul 2021 - Feb 2023 (1 year 8 months)

Phase II /Phase III studies-Therapeutical Area: Vaccines (Covid-19, Norovirus) Coordinated and scheduled protocol-related visits including site selection, initiation, interim monitoring visits and close out visits. • Achieve role promotion from Junior Clinical Research Associate to Clinical Research Associate I on Nov2022. • Ensure clinical trial in accordance with protocol in Colombia and Perú sites. • Act as central monitor, for safety procedures follow up (SAEs report, pregnancy, SUSARs) to ensure adequate and prompt reporting to regulatory authorities. • Completion of recruitment plan for Covid-19 study, around 600 active treatment patients in assigned sites.

Third Party Patient Support Program Coordinator

Novartis

Oct 2020 - Jul 2021 (10 months)

Guarantee oversight of key performance indicators of patient support programs of Pharma division in Andean Cluster (Colombia, Ecuador, Perú). • Active participation in PSP internal audits, establishing improvement plans and CAPAs. • Develop control and traceability of patient materials distribution. • Ensure administrative tasks such as purchase order, payments for external service providers.

Patient Oriented Program Coordinator

Novartis

Oct 2019 - Oct 2020 (1 year 1 month)

Guarantee oversight and follow up of external services providers regarding compliance of corrective and preventive actions associated with Patient Safety, Compliance, Legal, Quality among others. • Audit and monitor external service providers to ensure the operation works under high quality standards.

Alejandra Rubio

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