suneetha Chamarthi

Clinical research, regulatory affairs, and healthcare quality professional with an M.Sc. in Regulatory Affairs, Bachelor of Pharmacy, current CITI ICH-focused Good Clinical Practice training, TCPS 2 CORE-2022 certification, and 3+ years of healthcare operations experience at Optum. Experienced in clinical documentation review, document tracking, quality audits, discrepancy resolution, project coordination, stakeholder communication, regulatory documentation, and process improvement. Progressed from Medical Coder to L2 Auditor within one year while maintaining approximately 98% quality across high-volume patient and clinical records. Industry-sponsored regulatory project experience includes coordinating sponsor meetings, tracking action items and project timelines, preparing structured technical and clinical documentation, and supporting documentation quality and submission readiness. Strong organizational, written communication, multitasking, and MS Office skills applicable to Clinical Trial Assistant and clinical operations environments.

• Administrative Support
• Cross-Functional Collaboration
• Microsoft Excel
• Microsoft Outlook
• Microsoft Word
• Process Improvement
• Project Coordination
• Gestion de projet
• Assurance qualité
• Salesforce
• Travail d’équipe

1. Medical Coder | L2 Auditor

   Optum Healthcare and Technology

   août 2021 to août 2024

   Chennai, India

   • Progressed from Medical Coder to L2 Auditor within the first year based on consistent performance, coding accuracy, quality standards, and ability to independently review complex clinical documentation. • Maintained an average 98% quality accuracy rate while reviewing high-volume patient records, physician notes, diagnostic reports, operative documentation, and treatment records across major healthcare projects including WellMed, Anthem, and BMG. • Performed clinical documentation review, source-data validation, and coding using Optum EncoderPro, Epic, eClinicalWorks, Salesforce, and client healthcare systems, with secure access to remote environments through Citrix. • Assigned and validated ICD-10-CM, CPT, and HCPCS Level II codes by applying medical terminology, anatomy, physiology, pharmacology, and applicable coding guidelines. • As an L2 Auditor, conducted quality audits of coded records, identified coding and documentation discrepancies, analyzed recurring error patterns, and provided corrective feedback to support accuracy and continuous improvement. • Reviewed incomplete, inconsistent, or conflicting clinical information and coordinated with coding teams, quality personnel, operations staff, and healthcare stakeholders to clarify documentation and resolve discrepancies. • Performed root-cause analysis of coding errors, claim rejections, and documentation issues and supported corrective actions, quality monitoring, and process-improvement initiatives. • Managed multiple client workflows and high-volume assignments while consistently meeting quality, productivity, confidentiality, and turnaround-time requirements. • Maintained compliance with CMS coding guidelines, HIPAA requirements, payer policies, client-specific procedures, and organizational quality standards while handling protected health information.

2. Pharmaceutical Laboratory Trainee

   Pharma Deep Remedies

   déc. 2019 to Aujourd’hui

   India

   • Supported sample preparation, analytical data recording, and laboratory documentation for pharmaceutical quality-control activities. • Gained practical exposure to High-Performance Liquid Chromatography (HPLC), UV spectroscopy, and dissolution testing while following established laboratory procedures.

1. Northeastern University

   Master of Science, Regulatory Affairs

   Toronto, ON

   2024 to 2026

2. Vijaya Institute of Pharmaceutical sciences for women

   Bachelor of Pharmacy, Pharmacy

   India

   2017 to 2021

• Pharmacy Council of India Registration

  Pharmacy Council of India

• TCPS 2: CORE-2022 – Course on Research Ethics

• GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus), Basic Course

  CITI Program