Nathiele Lopes

Strong experience in Phase II-III global oncology trials, top-tier recruitment performance, and data quality excellence. Across 30+ studies, consistently positioned my sited as top recruiters in Brazil and often among the top 3 globally. Successfully reduced query backlogs by up to 95% and improved query turnaround from >15 days to 3-5 days.

Experienced with Astrazeneca audits (with only 5 minor findings fully resolved), process optimization, creation of protocol-specific source document templates, EDC validation, UAT, and CRF/EDC improvements. Skilled in iMedidata, RAVE, Veeva, Inform, IWRS, Medable, Clario and REDCap.

Clinical Research Recruitment at P3 Life Pesquisa Clínica (2026-05 – Present)

• Conduct pre-screening of potential clinical trial participants based on study-specific inclusion and exclusion criteria, assessing initial eligibility prior to referral to clinical research sites. Therapeutic areas: chronic kidney disease, cardiovascular disease, heart failure, hypertension, diabetes, fatty liver disease, Alzheimer's disease, schizophrenia, and depression.
• Develop and structure study-specific patient screening scripts based on clinical trial protocols and eligibility criteria, in collaboration with clinical research sites.
• Review and interpret inclusion and exclusion criteria to translate protocol requirements into standardized and patient-friendly pre-screening questionnaires and workflows.
• Conduct patient interviews to collect relevant medical history, current medications, previous treatments, diagnoses, and other study-specific information required for pre-screening.
• Request, review, and organize supporting medical documentation and patient information to facilitate site-level eligibility assessment.
• Refer potentially eligible patients to contracted clinical research sites, providing pre-screening information, relevant medical history, and supporting documentation to the study team.
• Coordinate communication between patients and clinical research sites throughout the referral process, ensuring accurate and complete transfer of information.
• Maintain standardized screening workflows and documentation while ensuring alignment with study protocols and site-approved requirements.
• Support patient recruitment activities across multiple therapeutic areas and clinical trial indications.

Clinical Data Manager at EDETEK Inc. (2024-01 – 2025-01)

• Reviewed eCRF specifications and validated programming outputs against CRF annotations to ensure accuracy and consistency.
• Participated in multiple UAT cycles, identifying critical issues (e.g., non-functioning pages and incorrect field behavior) prior to go-live.
• Developed and maintained the Data Quality Review Plan (DQRP) and supported Raw Data Validation (RDV), including SAE reconciliation and medical coding checks.
• Reduced unnecessary query generation by improving communication and clarification with programmers and medical reviewers.
• Acted twice under urgent timelines, completing two full-day DBL cleaning sprints to meet accelerated deadlines.
• Trained as backup Lead Clinical Data Manager and provided support to the Safety Team, resolving many MedDRA coding discrepancies.

Lead Clinical Research Coordinator at WCG ThreeWire (2022-01 – 2023-01)

Providing services to AstraZeneca PH, conducting a Breast Cancer Clinical Trial.

• Contributed to placing the site among the top recruiters in Brazil and within the top 3 globally.
• Hired specifically to improve data quality: reduced query backlog by ~95%, leaving only medical-dependent items.
• Improved query turnaround from >15 days to 3–5 days, meeting sponsor KPIs.
• Ensured zero pending items before every monitoring visit, audit, DBL or close-out.
• Maintained all data entry within 48 hours, consistently.
• Fully responsible for site operations and data integrity, working directly with sponsor teams.
• Led all corrective actions from the AstraZeneca audit (5 minor findings fully resolved).

Senior Clinical Research Coordinator at Neoplasias Litoral (2020-01 – 2024-01)

• Lead CRC for 18+ global Phase II–III oncology trials - lung, prostate, breast. With 5 studies repeatedly ranked as top recruiter globally.
• Eliminated loss to follow-up: 0 LTFU events across all my enrolled patients during 4 years.
• Created protocol visit-specific source document templates, improving visit structure and driving ~99% data accuracy.
• Standardized SOPs and templates for IC procedures, biological sample collection, shipment, and visit execution.
• Delivered many regulatory submissions, with only two rejections due to sponsor documentation (all corrected).
• Recognized by MSD for exceptional performance contributing to an accelerated DBL timeline.

Bachelor of Science (B.S.) in Biomedicine – Centro Universitário Leonardo da Vinci – UNIASSELVI (2025-01 – 2029-01)

MBA in Clinical Research – Centro Universitário Internacional – UNINTER (2023-01 – 2024-01)

Graduate Certificate in Process and Quality Management – Centro Universitário Internacional – UNINTER (2023-01 – 2024-01)

Bachelor in Environmental and Sanitary Engineering – Universidade do Vale do Itajaí – UNIVALI (2016-01 – 2022-01)