Chika Ekweghariri
Bronx,US
Summary
Detail-oriented operations professional managing high-value clinical studies up to $500K. Proven track record in accelerating research revenue through streamlined processes and efficient study management. Expert in cross-functional collaboration, policy compliance, and process improvement, consistently delivering results across large-scale operations.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Regulatory Coordinator
Montefiore Medical Center
03.2023 - Current
- Manage 40+ clinical trials (cumulative $500K), achieving 15% improved inspection success rates
- Fast-track study approvals and submissions, reducing timelines by 30%
- Oversee regulatory submissions across 30+ partner companies
- Drive 100% regulatory compliance while minimizing operational risks
- Streamline submission workflows, significantly reducing delays and cost overruns
- Coordinate comprehensive training programs for 50+ staff members
- Lead budget analysis and resource optimization initiatives
- Foster stakeholder engagement through efficient resolution of regulatory discrepancies
- Maintain pristine documentation systems and audit preparation processes
Regulatory Specialist
Hackensack University Medical Center
09.2020 - 03.2023
- Managed 30+ high-profile trials ($100K-$500K range)
- Accelerated study activation timelines by 25%
- Orchestrated training for 50+ professionals in GCP and systems
- Spearheaded regulatory oversight achieving pristine FDA audit records
- Implemented efficient sponsor and audit preparation protocols
- Leveraged advanced data analysis for real-time reporting and insights
Special Education Educator
East Orange School District
09.2013 - 06.2020
- Managed documentation systems for 50+ students annually
- Led cross-functional collaboration supporting 100+ students
- Achieved 40% reduction in operational inefficiencies
- Developed comprehensive progress tracking systems
Technical Support Representative
Veterans Affairs Medical Center
06.2013 - 07.2014
- Managed critical medical equipment maintenance and optimization
- Implemented efficient resource utilization strategies
Project Manager
University of Medicine and Dentistry
08.2011 - 05.2012
- Led multidisciplinary team developing patent-awarded medical device
- Coordinated with C-suite executives and manufacturing partners
- Managed technical documentation and patent compliance
Education
Bachelor of Engineering - Biomedical Engineering
Stevens Institute of Technology
Hoboken, NJ05.2012
Skills
- Operations Management
- Large-Scale Budget Oversight
- Process Improvement & Optimization
- Revenue Acceleration
- Cross-Functional Leadership
- Documentation Systems
- Data Analysis & Reporting
- Policy Implementation
- Regulatory Compliance
- Stakeholder Engagement
- Team Leadership
- Problem Resolution
- Training Development
Languages
English
Certification
- International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) Certificate – Transcelerate BioPharma Inc., or other recognized ICH GCP training providers.
- OSHA Certified
Timeline
Regulatory Coordinator
Montefiore Medical Center
03.2023 - Current
Regulatory Specialist
Hackensack University Medical Center
09.2020 - 03.2023
Special Education Educator
East Orange School District
09.2013 - 06.2020
Technical Support Representative
Veterans Affairs Medical Center
06.2013 - 07.2014
Project Manager
University of Medicine and Dentistry
08.2011 - 05.2012
Bachelor of Engineering - Biomedical Engineering
Stevens Institute of Technology
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