MAYUMI SASAKI

Within Gynecologic Oncology clinical trials, particularly in breast cancer, I work as study coordinator overseeing a range of international trials in various stages concurrently, ensuring seamless protocol execution and maintaining a patient-centric approach. Working on studies sponsored by internationally recognized pharmaceutical companies such as Roche, Novartis, MSD (Merck), Lilly, Pfizer and Amgen.

Key responsibilities:

• Conducted feasibility assessments and evaluated budgets for international clinical trials.
• Prepared and organized all documentation required for site initiation, ensuring compliance with protocol and regulatory guidelines.
• Scheduled all study procedures, maintaining close communication with the medical team and patients to prevent protocol deviations.
• Consistently met deadlines and milestones, effectively managing multiple tasks and responsibilities.
• Maintained precise documentation (subject files and study binders).
• Dispensed medications and provided instructions to patients regarding proper use, ensuring adherence to protocol requirements.
• Collected and entered data, including CRFs and questionnaires, as required by the protocol, maintaining data completeness and accuracy.
• Managed the inventory of laboratory kits, handled biological samples and prepared documents for shipment in compliance with IATA regulations.
• Resolved issues related to monitoring and audits/inspections activities, ensuring smooth study operations.
• Trained new employees on study coordination procedures and protocols.
• Checked and managed budgets and payments, including extra fees and procedures.
• Demonstrated expertise in several eCRFs, IWRS and imaging submission platforms and in RECIST evaluation.

Main achieved results

• Approximately 10 studies validated the approval of medications by FDA.
• Contributed significantly to the expansion of the company by achieving good results in our studies, resulting in an increased workforce and the number of studies undertaken, also establishing the organization as a reference for clinical research sites in Brazil.

Coordinated clinical trials for efficacy and safety of cosmetics

• Conducted informed consent process with the volunteers, answering their questions and concerns
• Performed different tests, accurately documenting the data
• Prepared the required documentation and reports, ensuring accuracy..

I began as a trainee, subsequently advancing to the role of a research assistant in trials related to osteoporosis and hormone replacement therapy.

• Conducted comprehensive chart reviews and accurately entered data
• Maintained precise documentation, adhering to strict protocols and guidelines
• Answered discrepancies in a timely manner.

The FDA approval to excpand the Verzenio label to include patients with high risk, HR+, HER2 -, Early Breast Cancer  is based on the results of this trial.

The FDA approval of Phesgo (breast cancer treatment that can be administered at home by health care professional) for People With HER2-Positive Breast Cancer is based on the results of this trial.

The FDA approval of Tecentriq in Combination With Abraxane for People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer is based on the results of this trial.

The FDA approval of Kadcyla for Adjuvant Treatment of People With HER2-Positive Early Breast Cancer is based on the results of this trial.

The FDA approval of Perjeta for Neoadjuvant HER2-Positive Breast Cancer is based on the results of this trial and Neosphere trial.

The FDA approval of Perjeta for Neoadjuvant HER2-Positive Breast Cancer is based on the results of this trial and Tryphanea trial.

The FDA approval of Perjeta for people with HER2-Positive Metastatic Breast Cancer is based on the results of this trial.

Analysis of organic nutrients of seeds of representative Cerrado (Brazilian savanna) species. 

Main concepts of clinical research, including study design, measurement, statistics, ethical, legal, monitoring, and regulatory considerations.