Lakshmi Pachava

Driven Clinical Research Coordinator with 4+ years of experience supporting Phase II–III industry-sponsored clinical trials in cardiology and oncology. Experienced in participant recruitment, informed consent, protocol implementation, AE/SAE reporting, study drug accountability, regulatory compliance, biospecimen handling, monitoring visits, and audit readiness. Proficient in REDCap, Medidata Rave, Veeva Vault, CTMS, and eTMF systems with a strong commitment to patient safety, data integrity, and successful trial execution.

Clinical Research Coordinator at Cross Creek Medical Clinic (2026-08 – Present)

• Support Phase II–IV clinical trial activities across gastroenterology, neurology, nephrology, diabetes, gynecology, and urology departments, following approved protocols and study procedures.
• Assist with participant prescreening, eligibility checks, informed-consent workflows, visit scheduling, and follow-up activities in coordination with the study team.
• Maintain accurate source documentation and study records; support source-data review, eCRF/EDC updates, and timely follow-up of data queries in accordance with site procedures.
• Document adverse events and support safety-reporting follow-up, escalating concerns to the investigator or designated study personnel according to protocol and site requirements.
• Coordinate packaging documentation and shipment tracking for 100+ biospecimen shipments, maintaining labeling accuracy, chain-of-custody records, and compliance with applicable handling and shipping procedures.
• Assist with preparation, coordination, and tracking of IRB/ethics committee submissions, amendments, and continuing-review documents, ensuring required documentation is complete and submitted within site timelines.
• Maintain essential study and regulatory documents, including applicable logs and Investigator Site File materials, and assist with monitoring-visit readiness and protocol-deviation follow-up.
• Leverage Veeva Vault and Medi data platforms to support clinical trial documentation, regulatory compliance, and clinical data management across Phase II–IV studies.

Clinical Research Coordinator at Research Centre of Clinical Studies (2025-02 – 2026-08)

• Managed day-to-day operations of six Phase II–III cardiology and oncology clinical trials.
• Coordinated participant recruitment, screening, eligibility verification, informed consent, and study visits.
• Processed and shipped 500+ plasma, serum, and tissue specimens while maintaining chain-of-custody.
• Reported 15+ AEs including 3 SAEs within regulatory timelines.
• Supported sponsor monitoring visits, audits, protocol amendments, and regulatory compliance activities.
• Improved participant visit attendance by 25% through proactive engagement strategies.

Clinical Research Coordinator at Kamineni Institute of Science (2021-06 – 2023-07)

• Coordinated multi-site Phase II–III cardiology studies from startup through database lock.
• Managed informed consent, medical history intake, medication reconciliation, and study documentation.
• Prepared IRB/EC submissions, protocol amendments, continuing reviews, and safety reports.
• Resolved 80+ clinical data queries and collaborated with sponsors and data management teams.
• Trained 8 new coordinators on study workflows and ICH-GCP requirements.
• Supported 18 monitoring visits and a federal audit with zero major findings.

Clinical Research Assistant at Kamineni Institute of Science (2020-01 – 2021-05)

• Assisted with participant recruitment, screening, informed consent, and study visit activities.
• Performed vital signs collection and supported clinical procedures.
• Maintained regulatory documentation and inspection-ready study files.

Master of Science in Health Data Science – Saint Louis University (2025)

Bachelor of Pharmacy – Osmania University (2020)