Clinical Research Operations Analyst

Charuta Kale

Clinical Research & Operations Analyst

Ohio, USA ************@*****.***

Professional Summary

Experienced clinical research professional with 5+ years of cross-functional coordination across Phases I–III trials and 10+ years of scientific research. Proven track record in process improvement, site/stakeholder engagement, SOP and document creation, and regulatory compliance. Adept in using systems like Oracle, RAVE, and OnCore to manage study workflows, queries, and data reporting. Recognized for strategic thinking, problem resolution, and translating complex requirements into actionable steps. Seeking a remote or flexible job opportunity where I can apply transferable skills from my opportunities in research roles.

Core Competencies

• Clinical Trial Workflow Analysis

• Stakeholder Communication

• Business Process Documentation

• Data Integrity & Query Management

• Risk Mitigation & Compliance

• SOP Development & Regulatory Alignment

• Veeva Vault Oracle RAVE OnCore

• GCP, FDA, IRB Regulations

• Cross-Functional Team Support

Professional Experience

Clinical Research & Operations Analyst (CRA II)

Biorasi – Remote (Sep 2022 – Apr 2025)

- Collaborated with stakeholders to track site performance, regulatory timelines, and data flow across 12+ sites and 3 concurrent trials

- Documented study processes, supported vendor and sponsor communications, and ensured adherence to GCP and internal SOPs

- Led site training and onboarding, streamlining operations and reducing data entry errors

- Used systems like Oracle, Veeva Vault, and RAVE to support data integrity and compliance

- Acted as liaison between clinical operations and project teams, flagging risks and driving resolution on protocol deviations

Clinical Research Associate I

IQVIA – Remote (Jan 2022 – Sep 2022)

- Monitored site activities and collaborated with cross-functional teams to ensure operational alignment with protocols

- Enhanced subject recruitment planning and documented workflow changes to optimize enrollment processes

- Supported protocol compliance review and data query resolution using EDC platforms

Clinical Research Coordinator / Assistant

The Ohio State University – Columbus, OH (Feb 2020 – Sep 2021)

- Coordinated study start-up, IRB submissions, and audit preparedness documentation

- Assisted in developing site workflows for specimen collection, data entry, and patient scheduling

- Supported EMR integration for clinical trial data and compliance tracking

Education & Certifications

Certified Clinical Research Associate – Qtech Professional Development Center, NJ (2014)

MPH (Epidemiology) – University of Texas, School of Public Health

MS (Virology) – National Institute of Virology, India

BS (Biotechnology) – University of Mumbai, India

Technical Skills

Oracle Veeva Vault RAVE OnCore EPIC Microsoft Office Suite CTMS eTMF Systems

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