Kaho Onomichi
Assistant Director Of Clinical Research
New York,NY
Summary
Strategic and analytical clinical research leader with 10+ years of experience across CRO (2 years) and academic (8+ years) settings, specializing in clinical operations, line management, end-to-end trial delivery, and financial stewardship. Proven ability to direct 30+ Phase I-IV oncology and MS studies from start-up through close-out, driving resource allocation, quality assurance, and operational optimization. Expert in multidisciplinary team onboarding, performance management, protocol execution, and strict adherence to ICH GCP guidelines. Recognized for data-driven problem solving and delivering innovative, partnership-focused solutions that improve study outcomes.
Overview
13
13
years of professional experience
Work History
Assistant Director of Clinical Research
Columbia University Irving Medical Center, Multiple Sclerosis Center, Department of Neurology
10.2023 - Current
- Direct end-to-end process of 30+ research projects, including Phase I – IV MS and oncology (CAR-T) clinical trials, ensuring financial stewardship through budget forecasting, contract/scope changes, and milestone achievement to enhance operational quality.
- Provide direct line management, coaching, and career development for 8+ clinical research staff, overseeing onboarding, performance appraisals, and strategic resource allocation to enhance team effectiveness.
- Oversee regulatory submission governance and data management operations, providing executive guidance to enhance full ICH GCP compliance and timely IRB approvals.
- Foster interdisciplinary collaboration and maintain strong sponsor, vendor, and CRO partnerships; lead operational strategy during site feasibility reviews and qualification meetings present site capabilities and optimize recruitment.
- Foster interdisciplinary collaboration and maintain strong sponsor, vendor, and CRO partnerships; lead operational strategy during site feasibility reviews and qualification meetings, presenting site capabilities and optimizing recruitment strategies.
- Develop SOPs, risk frameworks, and compliance training programs, utilizing data-driven analytics and key performance indicators (KPIs) to monitor project performance and ensure compliance with institutional policies and regulatory requirements.
- Deliver subject matter expertise in research operations and participant retention strategy, focusing on project timelines, data management, and regulatory compliance.
Research Project Manager
Columbia University Irving Medical Center, Multiple Sclerosis Center, Department of Neurology
06.2019 - 10.2023
- Oversaw the study start-up and close-out for 25+ industry-sponsored and NIH-funded clinical trials, and biorepository studies, streamlining research operations.
- Managed regulatory submission workflows for initial IRB approvals, amendments, and annual reviews, ensuring timely study activation.
- Collaborated with PIs and cross-functional teams to develop recruitment strategies and participant retention plans, monitoring trial processes to support informed decision-making.
- Led a team of six clinical research coordinators and interns, supervising, mentoring, and conducting performance evaluations to enhance team effectiveness.
- Developed core trial documents, including CRF and informed consents, while supervising data collection and document management to maintain study integrity.
- Ensured audit readiness by facilitating site audits and quality assurance, reviewing compliance, conducting risk assessments, implementing CAPAs, coordinating budget reviews and invoice reconciliation.
- Coordinated research project timelines, deliverables, and stakeholder communications across cross-functional teams.
Senior Clinical Research Coordinator
Columbia University Irving Medical Center, Multiple Sclerosis Center, Department of Neurology
04.2017 - 06.2019
- Partnered with principal investigators to launch, execute, and monitor 5+ Phase I-III trials and longitudinal studies across multiple research workflows.
- Supervised four junior clinical research coordinators on protocol adherence, recruitment support, study procedures, and data quality.
- Managed regulatory processes supporting FDA, IRB, and DSMB compliance for active studies and study documentation.
- Coordinated study-related communications with investigators, sponsors, and internal teams to keep timelines and expectations aligned.
- Supported protocol adherence, participant recruitment strategies, and quality data collection across ongoing research studies.
Clinical Research Coordinator
Massachusetts Eye and Ear, Department of Anesthesia
03.2016 - 08.2016
- Coordinated subject enrollment and data collection for Phase IV pediatric trial and retrospective studies, enhancing study integrity and participant engagement.
- Maintained research data and regulatory documents, including IND submissions and study databases, supporting compliance and facilitating study progress.
- Liaised with IRB on approvals, adverse events reporting, and annual study updates, ensuring regulatory compliance and safeguarding participant welfare.
- Department of Anesthesia
Site Operations Associate I
Ora, Inc., Allergy Division
03.2014 - 03.2016
- Facilitated ophthalmic Phase III clinical trials across the U.S. and Japan, ensuring protocol compliance and performing protocol-specific procedures.
- Organized regulatory binders, source documents, and CRFs, ensuring compliance through thorough source data verification.
- Screened, recruited, and enrolled patients while managing drug reconciliation and providing site training to ensure protocol adherence.
- Oversaw daily operations to streamline workflow and enhance efficiency., coordinating activities and ensuring efficient workflow.
Education
M.S. - Clinical Research
Massachusetts College of Pharmacy and Health Sciences (MCPHS) University
Boston, MA12-2016
B.S. - Public Health
Colby-Sawyer College
New London, NH12-2013
Skills
- Staff management
- Budget forecasting
- Strategic planning
- Regulatory compliance
- Project management
- Business development
- Operations management
- Site activation and Study close out management
- Risk management
- Creative direction
- Proficient in EDC, REDCap, Epic, Microsoft Excel, PowerPoint, Word, Outlook, OneNote, Teams, CTMS
- Fluent in Japanese and English
- SAS, SPSS, STATA
Certification
- Phlebotomy
- Certificate in Administration of Sponsored Projects
- ACRP Certified Clinical Research Coordinator (CCRC)
Presentations & Teaching
- Co-Instructor, "Clinical Research Coordinator Onboarding Training", Columbia University Irving Medical Center, New York, NY, October 2026.
- Presenter, “Extended Interval Dosing Study: Building Better Internal Team Collaboration.” Invited Speaker at the 2023 Columbia University Irving Medical Center Neuroimmunology Retreat, New York, NY, June 2023.
Timeline
Assistant Director of Clinical Research
Columbia University Irving Medical Center, Multiple Sclerosis Center, Department of Neurology
10.2023 - Current
Research Project Manager
Columbia University Irving Medical Center, Multiple Sclerosis Center, Department of Neurology
06.2019 - 10.2023
Senior Clinical Research Coordinator
Columbia University Irving Medical Center, Multiple Sclerosis Center, Department of Neurology
04.2017 - 06.2019
Clinical Research Coordinator
Massachusetts Eye and Ear, Department of Anesthesia
03.2016 - 08.2016
Site Operations Associate I
Ora, Inc., Allergy Division
03.2014 - 03.2016
B.S. - Public Health
Colby-Sawyer College
M.S. - Clinical Research
Massachusetts College of Pharmacy and Health Sciences (MCPHS) University