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Kritika

Clinical Trial Assistant

Contacto

United States
Disponible en CazVid
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Competencias

Clinical Research

Demonstrated experience with Clinical Research.

Clinical Trials

Demonstrated experience with Clinical Trials.

GCP

Demonstrated experience with GCP.

FDA

Demonstrated experience with FDA.

IRB

Demonstrated experience with IRB.

Educacion

Master's, Public Health, Epidemiology
University of Texas Health Science Center
Completed 2025
Bachelor's, Dental Surgery
Bharati Vidyapeeth Deemed University
Completed 2022

Resumen

Clinical Trial Assistant open to new opportunities

Experiencia

Clinical Research Coordinator

UnitedHealth Group
Jun 2025 - Present

Coordinated data collection and quality review across 5M+ patient and claims records in a GCP-aligned reporting environment, supporting protocol compliance monitoring.. Reviewed EDI 837/835 claims and clinical documentation to flag AE/SAE-relevant discrepancies.. Built and maintained Power BI/Tableau dashboards tracking site performance, quality metrics (HEDIS), and risk indicators.. Performed risk stratification (RAF/HCC) analysis to support patient eligibility screening and recruitment targeting.. Maintained TMF-aligned data repositories via AWS Redshift/Azure Data Factory pipelines.. Led cohort analysis and predictive modeling (Python) to identify high-risk patients for early intervention.. Implemented data validation frameworks safeguarding PHI/PII and ensuring HIPAA/GCP-aligned data handling.. Partnered with clinical, finance, and actuarial teams — coordinating in a manner consistent with PI/sponsor communication — to translate insights into site-level operational improvements.

Clinical Research Associate

Spikewell
Nov 2024 - Apr 2025

Extracted and validated multi-source EHR and claims data supporting site monitoring and source data verification.. Conducted exploratory analysis on readmission and utilization trends, informing patient recruitment strategy and protocol-level decisions for population health initiatives.. Developed automated Power BI/Tableau dashboards tracking clinical KPIs, enabling real-time site management and stakeholder reporting.. Validated HEDIS numerator/denominator logic to support CMS-compliant quality submissions, applying the same rigor required for FDA/IRB reporting standards.. Designed SQL/Python data pipelines to streamline data ingestion.. Partnered with clinicians and IT teams to define KPIs and implement data-driven solutions supporting care delivery workflows.

Clinical Trial Associate

HCLTech
Aug 2022 - Jun 2023

Analyzed large-scale EHR and claims datasets, implementing GCP-aligned validation rules.. Developed predictive models (Python, R) for patient risk stratification, supporting recruitment eligibility screening and cost forecasting.. Built SQL-based data marts supporting site and utilization tracking.. Designed dashboards tracking HEDIS, readmission, and financial KPIs.. Ensured HIPAA-compliant data handling and governance documentation consistent with Trial Master File and audit-readiness standards.

Clinical Data Coordinator

Cybage Software
Feb 2021 - Jul 2022

Queried and transformed high-volume healthcare datasets (Oracle, MySQL, Redshift) supporting clinical and claims data collection initiatives.. Automated recurring operational and financial reports using Python (Pandas) and Power BI.. Performed trend and variance analysis on patient care and utilization data, identifying anomalies relevant to protocol compliance monitoring.. Enhanced AWS-based data pipelines (RDS, Data Pipeline), improving data accessibility and refresh reliability for reporting teams.. Collaborated with cross-functional stakeholders to gather reporting requirements and translate healthcare metrics into site-level insights.

Habilidades

Clinical ResearchClinical TrialsGCPFDAIRB
Publicado en CazVid - 24 sept 2026
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