Vijaya Gowthami Jaddu

1. Performed on-site and remote clinical research support activities for investigational products, ensuring adherence to protocol, ICH-GCP, and regulatory requirements. 2. Reviewed source documents, lab reports, and study records to verify data accuracy against the case report forms (ICF's) and to identify protocol deviations and data inconsistencies. 3. Assisted in site initiation, routine monitoring, and close-out activities by maintaining study documentation, following up on action items, and supporting query resolution with site staff. 4. Collaborated with investigators, coordinators, and internal clinical operations to support timely subject enrollment, visit compliance, and data clean-up.

1. Supported entry-level clinical research activities by reviewing medical and clinical literature to inform protocol design, endpoints, and safety/efficacy assessments. 2. Extracted, organized, and maintained structured clinical data and documentation to support study start-up and ongoing clinical operations. 3. Assisted senior CRAs and clinical leads with preparation of site-level materials, tracking logs, and study documentation in line with good clinical practice. 4. Gained foundational experience in clinical trial processes, including study start-up, documentation standards, and data review workflows relevant to CRA responsibilitie 5.Maintained inspection-ready trial documentation by producing monitoring visit reports/follow-up letters and keeping eTMF/TMF/ISF current; reconciled findings, improved site documentation quality, and coordinated vendor/supply trackers to support activation and study metrics.