Este perfil está escrito en inglés
Clinical Trial Assistant
Demonstrated experience with Clinical Research.
Demonstrated experience with Clinical Trials.
Demonstrated experience with GCP.
Demonstrated experience with FDA.
Demonstrated experience with IRB.
Clinical Trial Assistant open to new opportunities
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.
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.
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.
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.