Open to opportunities

Deepthi Suprabha

@deepthisuprabha

Site Lead Clinical Research Coordinator driving Phase I–IV trial execution through compliant study start-up and TMF readiness.

United States

Message

What I'm looking for

I’m looking for a clinical operations role where I can lead compliant Phase I–IV study start-up and site support—coordinating EC/IRB submissions, keeping TMF/eTMF audit-ready, improving recruitment and data quality, and partnering with cross-functional teams to hit milestones.

I’m a Clinical Research Coordinator/Site Lead with 5 years of experience supporting Phase I–IV clinical trial operations across the full study lifecycle. My focus is delivering strong study start-up, effective site activation, and dependable site support while maintaining ICH-GCP and SOP adherence.

In my current role, I lead end-to-end coordination of study start-up through close-out for Phase II–III gene therapy trials. I collect, review, and track regulatory and site-level critical documents, coordinate EC/IRB and regulatory submissions, and maintain TMF/eTMF documentation for audit and inspection readiness.

I serve as the operational liaison for sites and cross-functional stakeholders, helping resolve protocol-related issues quickly and escalating appropriately. I also monitor subject recruitment and enrollment, maintain data quality, and drive timely issue resolution through protocol and study-specific training, CAPA implementation, and follow-up.

Earlier in my career, I worked as a Primary Clinical Research Coordinator and Clinical Research Assistant I, coordinating oncology trials with participant recruitment, screening, consent, retention, and IRB regulatory documentation. I also started as a Research Associate executing laboratory projects using PCR, ELISA, and Western Blot—experience that strengthened my rigor with data integrity and experimental documentation.

Experience

Work history, roles, and key accomplishments

Current

Site Lead CRC

Current

Baylor Scott & White Medical Center

Nov 2024 - Present (1 year 8 months)

Led end-to-end coordination of study start-up through close-out for Phase II–III gene therapy trials, ensuring ICH-GCP, SOP, and sponsor compliance. Maintained TMF/ISF documentation for audit readiness and served as an operational liaison to sites and cross-functional stakeholders.

Study Start Up ICH GCP Regulatory & Site Level Documentation Audit Readiness EDC Data Query Support Cross functional Coordination

Primary Clinical Research Coordinator

Revival Research Institute

May 2023 - Nov 2024 (1 year 6 months)

Led study start-up and site activation (PSV, SIV) for multiple studies across multiple therapeutic areas, supporting timely study milestones. Prepared, submitted, and tracked EC/IRB and regulatory submissions, maintained data quality and query resolution in EDC systems, and executed close-out activities with TMF archival and audit readiness.

Study Start Up SIV)IRB Submission Regulatory Compliance Data Query Resolution Data Quality TMF Audit Readiness Study Tracking

Clinical Research Assistant I

UT Southwestern Medical Center

Nov 2021 - Apr 2023 (1 year 5 months)

Coordinated oncology clinical trials by recruiting, screening, consenting, and retaining participants in compliance with IRB-approved protocols and federal regulations. Prepared and submitted IRB regulatory documents, monitored participant safety aligned with HRPP/FDA/sponsor guidelines, and coordinated study procedures with investigators and ancillary departments while maintaining regulatory comp

IRB Protocol Coordination Participant Recruitment Screening Participant Safety Federal Guidelines

Research Associate

Stempeutics Research Pvt Limited

Jan 2011 - Apr 2015 (4 years 3 months)

Executed laboratory research projects by following experimental protocols and timelines. Conducted PCR, ELISA, and Western Blot assays and documented/analyzed data in electronic systems to support data integrity and accurate reporting.

Project Timelines PCR Western Blot Data Documentation Data Analysis Data Integrity Reporting