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Kalpana Upreti

@kalpanaupreti

I deliver compliant oncology clinical trials from Phase I through Phase IV, supporting enrollment, data quality, and inspections.

India

Message

What I'm looking for

I'm looking to continue supporting high-quality oncology clinical trials, with responsibilities in regulatory compliance, site coordination, enrollment, data integrity, clinical documentation, and audit readiness.

I've supported more than 40 oncology clinical trials across Phase I–IV, PMS, real-world evidence, and observational studies, including DESTINY-Breast06, DESTINY-Breast07, SERENA-4, VERITAC-2, and TROPION Breast04.

I translate protocols into compliant site documentation, maintain protocols, ICFs, CRFs, IBs, and regulatory binders, and work with sponsors, CROs, IRBs, and investigators to resolve queries and implement amendments. My work spans breast, lung, gastric, head and neck, urothelial, ovarian, and melanoma studies.

I've handled sponsor audits, third-party audits, and DCGI inspections, including a 2012 DCGI audit with no critical findings. I was among the highest recruiters for DESTINY-Breast07 and recruited 60 patients in India for the Vanessa study.

Experience

Work history, roles, and key accomplishments

Senior Clinical Research Officer

Rajiv Gandhi Cancer Institute and Research Centre

Senior Clinical Research Officer with over 14 years of experience in oncology clinical trials (Phase I-IV). Coordinated cross-functional teams, ensured regulatory compliance, and managed clinical documentation for multiple studies.