Alexia Viridiana Montes Aparicio
Mexico City,CMX
Summary
Experienced with managing clinical trial documentation and maintaining regulatory compliance. Utilizes strong organizational skills to support efficient study operations and data accuracy. Knowledge of clinical trial processes and team collaboration ensures smooth project execution.
Overview
6
6
years of professional experience
Work History
Senior Clinical Trial Assistant (Sr. CTA)
WE ARE INFINITE-Bristol Myers Squibb -MEXICO-COLOMBIA
05.2025 - Current
- Regulatory planning of protocols in start-up, in early stages, collection of essential study documents, documentary collection for CTP, and QC.
- Preparation and distribution of site ISFs, including eISFs/ISF when applicable, while serving as the main point of contact for sites and overseeing site operations/monitor access to the eISF prior to SIV.
- Simplified site data collection by implementing EDC systems for improved accuracy and efficiency. (Veeva Vault)
- Provided administrative support such as scheduling meetings, taking minutes, as needed for project success.
- Acted as a liaison between clinical sites and sponsors for effective communication regarding protocol amendments, enrollment updates, or other pertinent information related to trials.
Senior Clinical Trial Assistant (Sr. CTA)
WE ARE INFINITE MEXICO
11.2024 - 05.2025
- Company Overview: (Summit therapeutics, Skingenix, Avimex, Bayer)
- Supported clinical trial execution by coordinating with cross-functional teams and ensuring regulatory compliance.
- Primary point of contact between research sites, sponsors, and the CRO, maintaining constant communication to ensure timely completion of study milestones. Proactively supported research sites in adopting and using electronic systems (EDC – Veeva Vault, Clinflash, Salesforce) and CTMS, ensuring accurate data management and timely deliverables.
- Coordinated all aspects of central ethics review board (IRB) submissions, Ministry of Health (MOH-COFEPRIS) dossiers, investigator initiation packages (IIPs), confidentiality agreements (CDAs), and other critical documents from trial initiation through completion.
- Trained and mentored new Clinical Trial Assistants (CTAs).Assisted with in-person and remote pre-screening visits for oncology and burn protocols.
- Supported the preparation, execution, and reporting of initiation, routine, and closeout visits for Phase 3 vaccine clinical trials.
- Closing of monitoring visits in vaccine studies: confirmation of adverse events, case follow-up, review of key records and team roles, preparation of closure reports.
- Assisting the CEO in meetings and documenting regulatory processes.
- Evaluating feasibility questionnaires and preparing initial packages for submission to COFEPRIS.
Clinical trial assistant (CTA)
ICON plc GLOBAL (Amgen)
05.2023 - 05.2024
- Application of GCP, BPD, and ALCOA++ principles in the review of critical site and study documents, such as financial disclosure forms (FDFs), accountability logs, and study protocols.
- Reconciliation of data and documents (informed consents, FDFs, training, CVs, major protocol deviations, and study metrics) prior to global audits.
- Advanced knowledge of Microsoft Word, Excel, and PowerPoint, including macro creation, pivot tables, search functions, and conditional formatting.
- Quality control and document archiving in Veeva Vault eTMF.
Research Assistant - IMSS
CENTRO MEDICO SIGLO XXI – UIMEN (UNIDAD DE INVESTIGACION EN MEDICINA EN ENFERMEDADES NEUROLOGICAS)
06.2019 - 02.2023
- Management and supervision of the Investigator Site File (ISF).
- Collaboration in molecular research on polymorphisms associated with drug-resistant epilepsy.
- Implementation of molecular techniques for the amplification of genetic material.
- Participation in the implementation of informed consent (ICFs) for study subjects in epilepsy drug resistant.
- Conducting experimental studies to optimize in DNA isolation and PCR and RT-qPCR amplifications.
Education
Diploma Course - Clinical Monitoring
Universidad Nacional Autónoma De México-Facultad De Medicina
Mexico City12.2024
Master of Science - Master in Health Sciences- (Clinical Research)
Instituto Politécnico Nacional- Escuela Superior De Medicina
Mexico City12.2023
Bachelor of Science - Veterinary Science
Universidad Nacional Autónoma De México
Cuautitlán, México12.2019
Skills
- Electronic data capture
- Informed consent process
- Regulatory submissions
- IRB and IEC submissions
LANGUAGES
English Intermediate
Spanish Advanced
Timeline
Senior Clinical Trial Assistant (Sr. CTA)
WE ARE INFINITE-Bristol Myers Squibb -MEXICO-COLOMBIA
05.2025 - Current
Senior Clinical Trial Assistant (Sr. CTA)
WE ARE INFINITE MEXICO
11.2024 - 05.2025
Clinical trial assistant (CTA)
ICON plc GLOBAL (Amgen)
05.2023 - 05.2024
Research Assistant - IMSS
CENTRO MEDICO SIGLO XXI – UIMEN (UNIDAD DE INVESTIGACION EN MEDICINA EN ENFERMEDADES NEUROLOGICAS)
06.2019 - 02.2023
Diploma Course - Clinical Monitoring
Universidad Nacional Autónoma De México-Facultad De Medicina
Master of Science - Master in Health Sciences- (Clinical Research)
Instituto Politécnico Nacional- Escuela Superior De Medicina
Bachelor of Science - Veterinary Science
Universidad Nacional Autónoma De México
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