JESSICA VASQUEZ ANGULO
Lima
Summary
Self-motivated clinical management coordinator with more than 10 years of experience in different task related whit clinical research management. Bringing comprehensive understanding of clinical operations, ICH GCP guidelines, ethics issues, regulation and documentation needs. Hardworking and passionate job seeker with strong organizational skills eager to secure entry-level as CRA position. Ready to help team achieve company goals. Detail-oriented team player with strong analytical thinking skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
13
13
years of professional experience
Work History
DATA MANAGEMENT COORDINATOR
ASOCIACIÓN CIVIL IMPACTA SALUD Y EDUCACIÓN
02.2023 - Current
- Managed relationships with clinical staff involved in the clinical data collection using various software tools for effective database management.
- Troubleshot data-related problems and coordinated maintenance or modifications to correct defects (DMC and/or central laboratory queries)
- Maintained high-quality records by enforcing strict adherence to established documentation standards and requirements (QC1, QC2, QC3)
- Monitor the implementation and follow-up of new clinical trials, pre-initiation testing of CRFs
- To read, interpret and analyze the different study documents in order to implement formats, checklists, tools, among others, that facilitate the daily work.
- Improved data accuracy by establishing efficient data management processes and guidelines. Identify and report trending errors.
- Improved data accessibility for team members by creating a centralized database tool.
- Reduced manual entry errors by implementing automated data validation procedures (collaboration tools).
- Developed comprehensive training materials to educate staff on best practices for data handling and storage. Training of new staff.
- Conducted regular audits of stored data, identifying and addressing inconsistencies or inaccuracies as needed.
- Elaborate a monthly report on the performance of the staff in charge.
DATA MANAGER
ASOCIACIÓN CIVIL IMPACTA SALUD Y EDUCACIÓN
02.2022 - 02.2023
- Processing of case report form (CRF) and electronic data in accordance with SOPs, GCP-ICH guidelines and sponsor requirements
- Support in coordination tasks as backup staff
- Updating of database with query resolutions
- Data entry of clinical data from source documents of phase III (HIV, TB and COVID-19) clinical research in order to make sure data is reported clearly, accurately, and securely
- Follow up on resolution of monitoring/audit findings and implement corrective and preventive measures
- Ensure chain of custody of all study documents and medical charts.
- Enhanced data accuracy by implementing robust data validation and quality control processes.
RESEARCH ASSISTANT
BIOGEN AGRO
09.2019 - 10.2021
- Conducting biopesticide efficacy tests in different levels (in vitro, greenhouse and field trials)
- Presented research findings at conferences, contributing to the advancement of the field.
- Utilized statistical software for data analysis, generating accurate insights into complex datasets.
- Developed comprehensive reports on research progress, keeping stakeholders informed and engaged.
- Conducted literature reviews to support hypothesis development and identify gaps in existing knowledge.
- Recording on internal system and follow up of requested material, equipment purchasing department
- Collaborated with multidisciplinary teams to develop innovative research methodologies and strategies.
- Managed laboratory equipment and resources, ensuring proper maintenance and optimal functionality.
CLINICAL TRIALS COORDINATOR
BLUFSTEIN CLINICAL LABORATORY
07.2012 - 06.2018
- Planning and implementing of Clinical Trials of Phase I, II and III (MDR/XDR TB, Breast Cancer, HIV and others)
- Optimized trial efficiency through meticulous data management and timely laboratory report submissions.
- Negotiated contracts with vendors for essential services at competitive rates, reducing trial costs without compromising quality.
- Utilized project management tools effectively to track progress across all phases of clinical trials, enabling quick response to any issues that arose during studies.
- Played an active role in preparing lab areas for audit visits from regulatory authorities ensuring compliance at all times.
- Gathered, processed, and shipped lab specimens.
- Developed comprehensive training materials for new staff members, increasing overall team proficiency.
- Managed budgets for multiple trials simultaneously, maintaining financial accountability and cost efficiency.
- Streamlined communication channels, fostering strong relationships with investigators, sponsors, and clinical teams.
- Prepare study document, complete, reviewing (feasibility questionnaires, SOPs, Clinical test quotations, reference values list, lab manual, and invoice processes reports.
- Maintained strict adherence to study protocols, contributing to high-quality trial outcomes.
- Enhanced patient recruitment by developing and implementing targeted advertising strategies.
CLINICAL STUDY BACKUP COORDINATOR
SAN MARTIN MEDICAL CLINICAL
02.2011 - 06.2012
- Coordination of Clinical Trials III (Diabetes Type II and Influenza)
- Following up of Clinical charts, visits and collection of biological samples, according to the protocol and visit
- Support in prepare regulatory package submission to ethics committee.
- Entered data, generated reports, and produced tracking documents.
- Gathered and organized materials to support operations.
- Managed project timelines for successful completion, ensuring milestones were met and deadlines were adhered to.
- Improved team productivity with regular communication and progress updates, fostering a collaborative work environment.
Education
Alumni - MBA
CENTRUM - Pontificia Universidad Católica Del Peru
Lima, Peru04.2025
DIPLOMA IN GOODCLINICAL PRACTICE, BIOETHICS, REGULATION,AND CLINICALTRIAL MANAGEMENT. - Clinical Research Management
Universidad Peruana Cayetano Heredia
Lima, Peru10.2017
Bachelor of Science - Biological Sciences
San Luis Gonzaga National University
Ica, Peru01.2011
Skills
- Collaboration tools MS Office, Google docs
- High level of English language
- Strong organizational skill and good time management
- Knowledge of Good Clinical Practice/ICH guidelines
- Strong communication and interpersonal skills
- Empathetic, Resilient, Analytical thinking
- Project Management
- Data Validation
- Database Management EDC (Oracle, Medidata, OpenClinica, RedCap)
- Data Quality Assurance
training
- DMC Virtual Introductory Workshop Frontier Science & Technology Research Foundation (Feb, 2023)
- GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) - Online course. CITI Program- INSPerú (Jul, 2022)
- Human Subject Research - Group 1: Researchers in human subjects - Online course. CITI Program - INS Perú (Jul, 2022)
- Monitoring. Online course. National Institute of Health - DAIDS (Mar, 2022)
- Essential documents National Institute of Health - DAIDS (Mar, 2022)
- Research in Global Health Emergencies: Ethical Issues - Online course. The Global Health Network (Feb, 2022)
- Responsible Biomedical Conduct of Research - Online course. CITI Program (Feb, 2022)
- Source documents National Institute of Health - DAIDS (Feb, 2022)
- Clinical Quality Management Plan. Online course. National Institute of Health - DAIDS (Feb, 2022)
- Protection of Human Subjects / Good Clinical Practice. National Institute of Health DAIDS (Feb, 2022)
- Scientific Session III: Peruvian Research for Tuberculosis Control. Ministry of Education (Dec, 2021)
- Good Clinical Practice (GCP). Online course NIDA-NIH (Dec, 2021)
Affiliations
- Yoga
references
- Cynthia Aguilar, TermoFisher Scientific, Latam Clinical Trials Manager, 51 989327782
- Rosmery Osorio, IQVIA, Country Site Activation Lead, 51 985994567
- Karina Vidarte, Unilabs (Blusftein Lab), Head Micobacterilogy Lab, 51 996120162
clinical research experience
- A multi-country, epidemiologic study to assess the interferon gamma release assay (IGRA) positivity, and to build capacity to conduct a tuberculosis (TB) vaccine efficacy study, in populations with a high TB disease burden., Data Management Coordinator, 23Feb2023, Currently
- A5300B/I2003B/PHOENIx Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB). A Multicenter Trial of the AIDS Clinical Trials Group (ACTG) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT)., Data Management Coordinator, 23Feb2023, Currently
- A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV Uninfected Cisgender Men and Transgender Women who have Sex with Men. STUDY 083, Data Management Coordinator, 23Feb2023, Currently
- Randomized Trial to Prevent Vascular Events in HIV - REPRIEVE (A5332), Data Management Coordinator, 23Feb2023, Currently
- Analytical interruption of antiretroviral treatment to assess immunological and virological to evaluate immunological and virological responses in participants who received VRC01 or placebo and who became HIV infection during the hvtn 704/hptn 085 study. HVTN 704/HPTN 085., Data Management Coordinator, 23Feb2023, Currently
- Coronary atherosclerosis and immune activation and infection by HIV and tuberculosis. CATHIA, Data Management Coordinator, 23Feb2023, Currently
- A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of a Heterologous Vaccine Regimen of Ad26.Mos4.HIV and Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals who Have Sex with Cis-gender Men and/or Transgender Individuals. VAC89220HPX3002; Phase 3. MOSAICO, Backup Data Manager, 12Apr2022, 22Feb23
- Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled clinical trial. / TBTC Study 31, ACTG Study A5349 / Fase III., Clinical Trials Coordinator - Įaboratoratory, Jan 2016, Jun 2018
- A Multicenter, randomized, Double-blind, Placebo-controlled, parallel group Trial to evaluate the safety and efficacy of Delamanid (OPC67683) /Protocol 242-09-213 / Fase III., Clinical Trials Coordinator - Įaboratoratory, Jul 2015, Oct 2017
Languages
English
Professional Working
Timeline
DATA MANAGEMENT COORDINATOR
ASOCIACIÓN CIVIL IMPACTA SALUD Y EDUCACIÓN
02.2023 - Current
DATA MANAGER
ASOCIACIÓN CIVIL IMPACTA SALUD Y EDUCACIÓN
02.2022 - 02.2023
RESEARCH ASSISTANT
BIOGEN AGRO
09.2019 - 10.2021
CLINICAL TRIALS COORDINATOR
BLUFSTEIN CLINICAL LABORATORY
07.2012 - 06.2018
CLINICAL STUDY BACKUP COORDINATOR
SAN MARTIN MEDICAL CLINICAL
02.2011 - 06.2012
Alumni - MBA
CENTRUM - Pontificia Universidad Católica Del Peru
DIPLOMA IN GOODCLINICAL PRACTICE, BIOETHICS, REGULATION,AND CLINICALTRIAL MANAGEMENT. - Clinical Research Management
Universidad Peruana Cayetano Heredia
Bachelor of Science - Biological Sciences
San Luis Gonzaga National University
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