Keerthi Kedasu
Summary
Clinical Research and Healthcare Quality professional with 10+ years of experience in clinical trial operations, medical imaging quality control, healthcare compliance, and data integrity review. Experienced in managing and auditing imaging data across CT, MRI, X-Ray, PET, Echocardiography, and Ultrasound modalities for global clinical trials.
Strong background in imaging QC workflows, protocol compliance, SAE reconciliation, SOP authoring, and regulatory standards including HIPAA, GCP, and 21 CFR Part 11. Currently supporting statewide quality improvement and incident management initiatives for California Department of State Hospitals through audit review, policy analysis, and healthcare data reporting.
Skilled in medical imaging review, clinical documentation, healthcare analytics, quality assurance, and cross-functional coordination with sponsors, investigator sites, CRAs, and project teams.
Overview
18
18
years of professional experience
Work History
Analyst II
California Department of State Hospitals
Sacramento, California
07.2024 - Current
- Support statewide quality improvement and compliance initiatives within the Standard Compliance Division through policy analysis, audit review, and incident management reporting.
- Perform healthcare data integrity checks across Incident Management and Clinical Risk Management systems to improve reporting accuracy and regulatory compliance.
- Develop data collection methodologies and analytical reports for Patient Safety Evaluation Systems and annual Patient Safety Culture Survey initiatives.
- Review hospital audit data and compliance studies to identify inconsistencies, policy gaps, and quality assurance risks.
- Recommend process improvements for healthcare data collection, reporting consistency, and quality assurance compliance workflows.
Project Specialist, Project Management
PAREXEL International Ltd.
05.2018 - 08.2021
- Managed imaging quality control workflows for clinical trials involving CT, MRI, X-Ray, and Echocardiography imaging data while ensuring protocol compliance and delivery timelines.
- Supported project managers with operational tracking, client coordination, budget alignment, and imaging trial execution activities.
- Coordinated Serious Adverse Event (SAE) reconciliation activities between investigator sites, CRAs, and sponsors to maintain data accuracy and regulatory compliance.
- Authored and maintained SOPs, Site Manuals, and project documentation to support audit readiness and eTMF compliance.
- Participated in sponsor meetings, client audits, database lock activities, and internal operational reviews.
Senior Imaging Research Associate
PAREXEL International Ltd.
08.2015 - 05.2018
- Led quality control and preliminary review of medical imaging data across CT, MRI, X-Ray, and Echocardiography modalities for clinical research studies.
- Trained and mentored Imaging Research Associates and Imaging Assistants on imaging workflows, QC procedures, and protocol compliance requirements.
- Authored project-specific imaging documentation including SOPs, Core Imaging Lab Manuals, and Site Manuals.
- Supported compliance monitoring activities related to GCP, HIPAA, and 21 CFR Part 11 standards across assigned projects.
- Conducted imaging audit checks and provided technical imaging support to clinical project teams.
Imaging Research Associate / Imaging Assistant
PAREXEL International Ltd.
05.2008 - 12.2011
- Performed imaging quality assurance checks and image processing activities across CT, MRI, PET, Ultrasound, X-Ray, and Echocardiography studies.
- Managed DICOM conversion, ROI measurements, digitization, and imaging database validation using Alice and third-party imaging software tools.
- Coordinated with investigator sites on imaging qualification activities, imaging issue resolution, and protocol compliance requirements.
- Maintained imaging tracking systems, study documentation, and project reporting spreadsheets for assigned clinical trials.
- Supported preliminary imaging reviews and QC follow-up activities for multi-site clinical research programs.
Education
Bachelors - Pharmacy
JNTU
01-2007
Skills
- Clinical Research
- Medical Imaging Quality Control
- Healthcare Data Integrity
- Clinical Trial Operations
- Regulatory Compliance
- SOP Authoring
- Healthcare Quality Assurance
- HIPAA Compliance
- GCP
- 21 CFR Part 11
Projects
- Clinical Trial Imaging QC & Compliance Management: 2015-2018
Managed imaging quality control workflows for multi-site clinical trials involving CT, MRI, X-Ray, PET, and Echocardiography imaging modalities. Conducted image validation, DICOM conversion, ROI measurements, and protocol compliance reviews while coordinating with investigator sites and clinical research teams.
Tools & Methods: Alice Imaging Software, DICOM workflows, ROI measurements, imaging QC review, HIPAA, GCP, 21 CFR Part 11
- Patient Safety Data Integrity & Healthcare Quality Reporting: 2024-2026
Supported statewide healthcare quality improvement initiatives through audit review, incident management analysis, and patient safety reporting. Developed data collection methodologies and reviewed healthcare compliance data for quality assurance consistency and reporting integrity.
Tools & Methods: Qualtrics, Healthcare audit review, compliance reporting, quality assurance analysis, Excel, Microsoft Forms, healthcare data validation.
- SOP & Clinical Documentation Development: 2018-2021
Authored and maintained SOPs, Site Manuals, and project-specific imaging documentation for clinical trial operations and audit readiness. Supported eTMF compliance and standardized operational procedures across clinical imaging workflows.
Tools & Methods: SOP authoring, clinical documentation, audit readiness, eTMF compliance, protocol documentation, MS word, PDF.
Supporting Skills
- DICOM Processing
- ROI Measurements
- SAE Reconciliation
- Audit Review
- Incident Management
- eTMF Compliance
- Alice Imaging Software
- Medical Imaging Analysis
- Policy Analysis
- Healthcare Reporting
- Cross-Functional Coordination
- Clinical Documentation
Timeline
Analyst II
California Department of State Hospitals
07.2024 - Current
Project Specialist, Project Management
PAREXEL International Ltd.
05.2018 - 08.2021
Senior Imaging Research Associate
PAREXEL International Ltd.
08.2015 - 05.2018
Imaging Research Associate / Imaging Assistant
PAREXEL International Ltd.
05.2008 - 12.2011
Bachelors - Pharmacy
JNTU