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Skills

  • Clinical trial coordination
  • Multilingual capabilities in Japanese
  • Patient informed consent process
  • Database lock preparation
  • Relationship development
  • Trial management
  • Regulatory compliance
  • Operational improvement
  • Phase I-IV trial management
  • Team management

Work Experiences

  • Achieved results across 18 sites.
  • Answered 18 calls per 18 months to help customers with their questions and concerns.
  • Achieved Excellence Award for excellence in managing ServiceNow clinical trials, delivering trials within budgets and anticipated timelines.
  • Gathered, analyzed, and modeled the data.
  • Achieved 21% retention in long-term phase.
  • Analyzed data trends and shared insights during cross-functional team reviews, maximizing data quality and protocol adherence.
  • Looked for industry trends on social media and through online sources.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Achieved enrollment targets the past year ahead of schedule.
  • Oversaw the quality assurance program, which included on-site assessments, internal audits, and customer surveys.

Summaries

  • Achieved a 65% reduction in data discrepancies.
  • Applied expertise in budget forecasting.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Consistently reduced expenses by 18%.
  • Consistently met protocol-driven outcomes.
  • Collaborated effectively with cross-functional teams.
  • Dedicated to learning, growing, and succeeding in Miscellaneous.
  • Clear understanding of performance reporting and team leadership as well as client relations training.
  • Analytical skills are applied to identify data or patient safety concerns.
  • Committed to safeguarding data integrity.

Accomplishments

  • Regularly interfaced with DSMB, ensuring timely reporting of safety data, contributing to a 45% reduction in serious adverse event reporting lag.
  • Served as a liaison between sponsors, CROs, and internal teams, ensuring 32% adherence to trial milestones and sponsor deliverables.
  • Conducted rigorous review of informed consent forms across 15 sites, improving patient recruitment by 70%.
  • Coordinated cross-functional team meetings to ensure timely protocol amendments that reduced overall trial delays by 52%.
  • Managed site communication plans, leading to a 74% reduction in missed monitoring visits in Miscellaneous.
  • Played a key role in organizing investigator meetings, contributing to improved communication and a 67% increase in recruitment speed.
  • Assisted in CTA negotiation with different stakeholders, reducing negotiation timelines and securing regulatory approval earlier than projected.
  • Played a pivotal role in negotiating with 12 participating sites, reducing contract finalization timelines by 85% weeks.
  • Reviewed and updated trial protocols, contributing to adaptive trial designs that accelerated patient recruitment by 18 months.
  • Optimized clinical supply chain for 16 clinical sites, maintaining 20% inventory accuracy throughout the study duration.

Affiliations

  • National Institutes of Health Clinical Center (NIH CC)
  • ISO/IEC 27001 Information Security Management Certification
  • Certified Clinical Research Coordinator (CCRC) - 2022
  • Public Responsibility in Medicine and Research (PRIM&R)
  • Association of Information Technology Professionals
  • American Health Data Institute (AHDI)
  • Collaborative Institutional Training Initiative (CITI Program)
  • Society of Women Engineers
  • American Medical Informatics Association
  • Lions Club

Certifications

  • Certified Clinical Trials Auditor (CCTA) - Beacon Labs, 2016
  • HIPAA Certification – Lakeside Partners, 2020
  • SAS Programming for Clinical Trials Certification - Vantage, 2015
  • Certified Drug Safety Associate (CDSA) - Brightline, 2015
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Apple Certified Associate (ACA)
  • Clinical Research Project Management Certification - Summit Group, 2024
  • Ethics and GCP in Human Research Training - Lakeside Partners, 2016
  • Certified Professional in Healthcare Quality (CPHQ) - Ironclad Systems 2021
  • FDA CFR Part 11 Compliance Training - Beacon Labs, 2018

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