Shravani

Accomplished Clinical Research Coordinator with 3 years of experience managing Phase II/III oncology, hematology, and rare disease trials. Proficient in EDC, eISF, and IRT platforms with a track record of maintaining strict GCP/FDA compliance, optimizing participant recruitment, and supporting successful audit outcomes.

Clinical Research Coordinator - Concept Clinical Services - Surat, Gujarat, India

(2023-05 - 2026-05)

• Therapeutic Area Expertise: Hematology, oncology and rare disease indications.
• Successfully coordinated Phase [II/III] global studies from initiation to close-out, by maintaining accurate and up-to-date case report forms and source documents for traceability while maintaining the Good Documentation Practice (GDP) and study protocols; proactively resolving queries along with oversight on management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials and maintenance of other essential st
• Monitored and recorded adverse events/Serious adverse events during clinical trials, managing study documentation for accuracy and regulatory compliance; followed clinical research protocols while conducting study visits in accordance with ICH/GCP and FDA regulations, thereby enhancing patient safety.
• Coordinated participant recruitment activities, screening patient records, databases, and doctor referrals to identify potential research study participants while ensuring adherence to study guidelines.
• Utilized electronic data capture (EDC), interactive response technology (IRT), electronic investigator site file (eISF), and electronic patient-reported outcomes (ePRO) for efficient clinical trial management.
• Supported on-site/remote monitoring visits, sponsor visits and internal audits.
• Facilitated communication among principal investigators, sponsors, and study participants to ensure seamless trial execution and maintain alignment on study objectives.

MSc. - Microbiology - Veer Narmad South Gujarat University (2021 - 2023)