ALEKHYA KORIBILLI

• Supported clinical study delivery from feasibility and start-up through ongoing site management, monitoring, and close-out, aligning work with protocol, ICH-GCP, SOPs, and applicable regulations.
• Coordinated site feasibility and selection activities and assisted with start-up deliverables, including collection and review of essential documents, EC/IRB and regulatory submissions, site activation, ICF customization, and study-system access.
• Monitored study conduct and site performance through on-site and remote monitoring, reviewing recruitment, enrollment, retention, visit status, compliance, data quality, protocol adherence, and operational issues against study requirements.
• Monitored AE/SAE reporting and safety-related activities in accordance with protocol and regulatory requirements.
• Performed remote monitoring, KRI reviews, and operational risk identification activities supporting study quality, compliance, and issue mitigation
• Reviewed source documentation, eCRFs, and data queries for completeness, accuracy, and consistency; followed up with sites and study teams to support timely resolution of data and quality issues.
• Identified protocol deviations, data discrepancies, safety-reporting gaps, and site compliance risks; escalated significant issues and supported root-cause analysis, CAPA, and risk-mitigation activities.
• Conducted centralized assessments of site performance, SDV/SDR completion, protocol deviations, and TMF review backlogs, escalating issues that could impact study quality and timelines
• Maintained and reviewed essential documents and eTMF records for completeness and compliance, supporting audit and inspection readiness and timely closure of documentation gaps.
• Coordinated site activation readiness, milestone tracking, stakeholder updates, and study execution support
  activities
• Tracked recruitment, study timelines, quality metrics, and monitoring performance; communicated emerging risks and operational issues to relevant stakeholders for timely action.
• Partnered with principal investigators, site staff, clinical project leads, data management, safety, regulatory, vendors, and other stakeholders; participated in study-team, investigator, and monitor meetings, training sessions, audits, and inspections.
• Supported site contract and budget-related activities by coordinating required documentation between sites and internal teams.
• Documented and monitored adverse events and protocol deviations to maintain study compliance.

• Conducted centralized monitoring across multiple global clinical trials in accordance with approved monitoring and risk-based monitoring
plans.
• Performed site-, country- and study-level risk assessments using clinical data, KRIs and performance trends to identify early signals.
quality risks and potential delivery issues.
• Analyzed clinical data through centralized monitoring platforms and analytics tools to identify inconsistencies, data-quality risks.
protocol/compliance signals and performance trends.
• Communicated findings, risks, escalations and recommended mitigation/follow-up actions to study teams, supporting proactive issue
management and study oversight.
• Documented centralized monitoring reviews and follow-up actions to support audit/inspection readiness and traceability of study-level
risk management.
• Supported development and maintenance of KRI dashboards and centralized monitoring logic, strengthening analytics workflows and
consistent risk review.
• Contributed to training and knowledge-sharing on centralized monitoring and RBM best practices.

• Monitored compliance of clinical trial sites with IQVIA study protocols to ensure adherence to regulatory standards.
• Reviewed source documents and case report forms to ensure data accuracy and integrity for regulatory submissions.
• Coordinated communication among investigators, coordinators, and sponsor teams to facilitate efficient information flow and issue resolution.

Coordinated day-to-day clinical trial activities in accordance with protocol, ICH-GCP and regulatory requirements, supporting participant safety and trial integrity. • Managed participant screening, recruitment, scheduling, visits, follow-up and informed-consent documentation. • Maintained source documentation, entered study data into EDC systems, resolved data queries and collaborated with investigators. sponsors and monitors for maintaining data quality. • Prepared and maintained essential documents, regulatory binders, and TMF documentation to ensure audit and inspection readiness. • Coordinated monitoring visits, audits, sponsor communications and action-item follow-up; reported AEs, SAEs and protocol deviations according to study and regulatory requirements.

• Organized patient appointments for clinical trials to maintain compliance with study schedules.
• Assessed informed consent documents for adherence to regulatory standards. forms and maintained compliant research documentation.
• Gathered source data meticulously to support accurate reporting in clinical trials. and updated case report forms accurately.