Jody Ho
Miami,FL
Summary
Dynamic Regulatory Analyst with extensive experience at the University of Miami, adept at managing clinical trials and ensuring regulatory compliance. Proven track record in project management and team collaboration, successfully overseeing high-volume oncology trials while optimizing workflows. Skilled in protocol review and submission, driving efficiency and compliance in clinical research environments.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Regulatory Analyst II
University of Miami, Miller School of Medicine
Miami, FL
12.2024 - Current
- Reduced the pre-pipeline timeline by 28% from 2024 to 2025 through workflow optimization and cross-functional coordination.
Regulatory Analyst I
University of Miami Miller School of Medicine
Miami, FL
02.2022 - 12.2024
- Analyzes regulatory requirements in clinical research to identify potential conflicts and ensure compliance with federal regulations and University policies.
- Conducts committee meetings with leadership to approve new cancer trials at Sylvester Comprehensive Cancer Center.
- Specializes in diverse site disease groups, including Breast, Gastrointestinal, Leukemia, and Lymphoma.
- Executes study initiation activities for Phase 1, Phase 2, and Phase 3 trials alongside investigators and sponsors.
- Manages a high-volume pipeline of oncology trials while optimizing team workflows.
- Reviews protocols, manuals, and other study documents for clarity and compliance.
- Collaborates with investigators, clinical managers, and ancillary teams to assess trial feasibility.
- Attends site qualification visits with investigators, sponsors, and CROs to secure approvals, and compile essential documentation.
- Modernized clinical trial tracking by implementing a collaborative, real-time system, phasing out Excel use, and improving cross-functional alignment in the pre-pipeline stage; authored detailed work instructions to standardize usage and ensure smooth onboarding.
- Co-led the development of our sponsor welcome packet to streamline the startup process by proactively addressing FAQs from sponsors, significantly improving startup efficiency to minimize delays in the pre-pipeline process.
Quality Control Team Lead
Innfocus
Miami, FL
07.2020 - 02.2022
- Ensured regulatory compliance for Quality Control across all manufacturing operations.
- Maintained ISO documentation to meet applicable regulations and standards.
- Facilitated management communications to secure timely approval of process and test data.
- Collaborated with purchasing and planning teams to align product procurement with production schedules.
- Streamlined document flow by applying effective organizational and multitasking skills.
- Produced and filed applications for various regulatory procedures and related documentation.
- Reviewed product specifications and customer requirements to guarantee compliance with necessary standards.
Education
MBA -
Florida International University
Miami, FLBBA -
Florida International University
Miami, FLSkills
- Project management and clinical research
- Work planning and prioritization
- Team collaboration
- Problem resolution
- Clinical trials oversight
- Protocol review and submission
- Regulatory submissions and compliance
- Process improvement
Certification
- CITI Human Subjects Research (HSR) with Group 1: Biomedical Researchers
- CITI Protection of Human Research Subjects. Good Clinical Practice and ICH (GCP)
Timeline
Regulatory Analyst II
University of Miami, Miller School of Medicine
12.2024 - Current
Regulatory Analyst I
University of Miami Miller School of Medicine
02.2022 - 12.2024
Quality Control Team Lead
Innfocus
07.2020 - 02.2022
MBA -
Florida International University
BBA -
Florida International University
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