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Bianca Prisco

@biancaprisco

Clinical research operations professional at Parexel supporting site activation and maintaining over 90% on-time closure of TMF quality issues.

Brazil

Message

At Parexel International, I support clinical trial delivery through site activation, documentation management, and coordination with sponsors, vendors, CRAs, and study sites. I maintained over 90% on-time closure of TMF quality issues while supporting TMF/eTMF maintenance and inspection readiness.

At CPQuali- Centro de Pesquisa Clínica, I coordinated activities for five clinical trials across multiple therapeutic areas and achieved approximately 70% patient retention and treatment adherence across assigned studies. I also supported protocol-required visits, safety reporting, and site operations, and standardized biological sample shipment scheduling as a trainee.

Experience

Work history, roles, and key accomplishments

Current

Senior Clinical Operations Assistant

Current

Parexel International

Jan 2026 - Present (9 months)

Lead site activation activities, coordinate ISF distribution, and maintain study trackers. Support monitoring activities and maintain >90% on-time closure of TMF quality issues.

TMF ETMF CTMS Site Activation New Investigator Training Document Management Study Trackers Vendor Trackers Monitoring support ICH GCP Veeva Vault Microsoft Office

Clinical Operations Assistant

Parexel International

Jan 2024 - Dec 2025 (1 year 11 months)

Managed CTMS, study trackers, and TMF/eTMF documentation. Coordinated site documentation, regulatory submissions, and site payment processes.

CTMS TMF ETMF Document Review Regulatory Submissions Site Payments Invoice Tracking Study Metrics ICH GCP Veeva Vault Microsoft Office

Clinical Research Assistant III

CPQuali - Centro de Pesquisa Clínica

Jan 2023 - Dec 2024 (1 year 11 months)

Coordinated activities for five clinical trials across multiple therapeutic areas. Achieved approximately 70% patient retention and treatment adherence across assigned studies.

Clinical Trials Protocol Compliance Source Documents Monitoring Visits Study Resources ICH GCP Microsoft Office

Clinical Research Assistant II

CPQuali - Centro de Pesquisa Clínica

Jan 2022 - Dec 2023 (1 year 11 months)

Conducted protocol-required study visits and patient follow-up activities. Reported SAEs and protocol deviations, and performed query resolution in eCRFs.

E CRF SAE Reporting Protocol Deviations Patient Scheduling Site Communications ICH GCP Microsoft Office

Clinical Research Trainee

CPQuali - Centro de Pesquisa Clínica

Jan 2021 - Dec 2022 (1 year 11 months)

Standardized biological sample shipment scheduling processes and conducted ECG procedures. Assisted in protocol-required participant visits and developed operational templates.

ECG Sample Shipment Management Protocol Visits Templates ICH GCP Microsoft Office