Katalina Londono

Clinical Trials Professional with 4+ years of experience across sponsor-side laboratory operations, site coordination, and regulatory affairs. Specializing in maintaining audit-ready eTMF/eReg files (Veeva Vault, Florence) for Phase I-III oncology trials, with a proven track record of zero critical findings in FDA inspections. Expert in cross-functional tracking, deviation reconciliation, and ensuring 100% on-time IRB regulatory milestones.

Regulatory Affairs Coordinator at University of Washington — Division of Medical Oncology (Jul 2024 – Aug 2026)

• Drive operational support for 18-21 concurrent Phase I-III hematologic-oncology trials across WCG, Fred Hutch, and UW IRBs, ensuring all submissions and communications are timely and compliant
• Deliver a 100% on-time IRB approval record for initial submissions and ~8-10 monthly protocol and ICF amendments, eliminating study delays and keeping trials on schedule
• Maintain audit-ready eReg/eTMF in Florence eReg, OnCore, SIP, and Veeva Vault; supported 2 sponsor audits and 1 FDA inspection with zero critical findings
• Serve as primary liaison for ~10 contract CRAs; pre-review investigator site files to resolve findings prior to monitoring visits
• Log and report all SAEs, SUSARs, and unanticipated problems for 21 studies within 24-hour timelines, fully meeting FDA and institutional requirements
• Lead quarterly deviation reconciliation for 21 hematologic-oncology studies and conduct 3-4 peer QC audits each quarter to verify GCP and SOP compliance
• Drive cross-functional alignment by leading study team meetings and monitoring visit prebriefs; prepare agendas, track action items, and follow through with investigators, coordinators, and CRAs to ensure alignment

Clinical Research Coordinator I at PPD (Thermo Fisher Scientific) (Nov 2023 – Jun 2024)

• Coordinated early-phase clinical trials, reviewed medical records to assess eligibility and performed informed consent and re-consenting for multiple concurrent studies
• Scheduled and coordinated clinic and study visits, aligning procedures and laboratory assessments with protocol windows
• Identified and reported adverse events per protocol and regulatory requirements in collaboration with investigators and nursing staff
• Performed source data QC, EDC data entry, and query resolution to meet sponsor data-lock deadlines

Research Lab Tech I/II at PPD (Thermo Fisher Scientific) (Jan 2022 – Nov 2023)

• Designed and implemented a QC system for pharmacokinetic sample collection and processing (daily audits and weekly feedback), reducing protocol deviations by 25% and shipping errors by 50%
• Prepared kits, processed plasma and serum specimens, and shipped samples to central labs in accordance with study guidelines and IATA/DOT requirements
• Maintained lab equipment logs and inventory

B.S. in Applied Health Sciences – Eastern Florida State College (Aug 2026)

Associate of Arts – Valencia College (Dec 2016)