Nandini Patel

- Supported day-to-day coordination of clinical research activities across all trial phases in compliance with ICH-GCP, SOPs, and regulatory requirements. - Assisted with subject screening, informed consent, and study visit procedures, ensuring protocol adherence and participant safety. - Maintained accurate source documentation, case report forms (CRFs), and ensured timely query resolution in collaboration with the study monitor. -Prepared and maintained regulatory and study documentation, including investigator site files and ethics submissions. - Facilitated communication between investigators, sponsors, and cross-functional teams to ensure operational efficiency and issue resolution. - Supported study start-up activities, including site initiation, document preparation, and coordination of lab kits and study supplies. - Conducted data collection, transcription, and verification to ensure high-quality and audit-ready research data. - Assisted with tracking project milestones, visit schedules, and deliverables to support timely trial progression.

- Coordinated clinical trials, ensuring compliance with GCP, study protocols, and applicable regulatory requirements. - Collaborated with cross-functional teams to ensure timely and compliant study execution. - Monitored and documented adverse events, patient safety, and vital trial procedures. - Prepared clinical study documentation, ensuring 100% audit readiness and compliance with ICH, FDA, and regulatory standards. - Conducted site monitoring visits and source data verification (SDV) to maintain data integrity. - Managed Case Report Forms (CRFs), resolving data queries to enhance data quality. - Oversaw Trial Master File (TMF) maintenance and supported site initiation visits (SIVs), ensuring protocol training and SOP compliance. - Coordinated trial materials, optimizing inventory management to reduce shortages by 10%. - Led equipment setup and safety protocol adherence, ensuring hygiene and safety standards. - Managed site contracts, budgets, and enrollment logs, ensuring accurate data and protocol compliance.

Assisted in the conduct of Phase I–III clinical trials by performing participant screening, vital sign assessments, and adverse event monitoring in compliance with study protocols, GCP guidelines, and SOPs. Supported data collection, regulatory documentation, and study visit coordination while ensuring participant safety and data integrity.