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Skills

  • Specimen collections
  • Patient recruitment strategies
  • Delegation and team leadership
  • Audit preparation and findings resolution
  • Multilingual communication (e.g. Japanese)
  • Supervision
  • Clinical site staff training and mentoring
  • Electronic Case Report Forms (eCRF) systems
  • Multitasking in high-pressure environments
  • Clinical site regulatory compliance monitoring

Work Experiences

  • Clinical trials for disorders like metric and system were coordinated by me.
  • Collaborated with KOLs.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Assisted in selecting CROs and vendors.
  • Conducted regular archiving audits.
  • Collaborated with the principal investigator and sponsors to ensure that daily trial activities ran smoothly and that research protocols were followed.
  • Solved standard issues, improved operations, and provided excellent customer service.
  • Looked for industry trends on social media and through online sources.
  • Completed reconciliations without errors in 2015.
  • Built relationships with external stakeholders, including patient advocacy groups and KOLs, to ensure clear communication and study alignment.

Summaries

  • Achieved savings by negotiating with vendors.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Clinical Project Coordinator with a focus on cross-functional collaboration, boosting team efficiency and reducing bottlenecks by fostering open communication channels.
  • Exceptionally well-organized and thorough, with excellent planning and problem-solving skills.
  • Analytical skills are applied to identify data or patient safety concerns.
  • Achieved a 77% reduction in study delays.
  • Clinical Project Coordinator with a robust track record.
  • Adept at using eCRF systems.
  • Achieved Innovation Award for excellent protocol adherence.
  • Achieved a database lock without critical discrepancies.

Accomplishments

  • Authored and updated study documentation including site monitoring plans, significantly reducing discrepancies by 46% during site audits.
  • Directed the submission process for 9 successful IRB applications, achieving approval for new protocols within 10 weeks.
  • Collaborated closely with cross-functional teams to facilitate the timely execution of site selection and initiation visits for 16 global trial sites.
  • Managed budget forecasts and reconciliations for clinical trials, ensuring studies were completed within 83% of the initial budget plans.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Served as the primary liaison between clinical trial sites and sponsors, driving timely delivery of critical study data and maintaining a 27% compliance rate.
  • Developed project timelines utilizing Gantt charts, effectively meeting all clinical study milestones and adhering to regulatory deadlines.
  • Provided ongoing study updates and facilitated communication between 14 global trial sites, ensuring all sites met regulatory and enrollment timelines.
  • Designed study protocols in collaboration with clinical stakeholders to ensure alignment with regulatory requirements, achieving FDA approval within 8 months.
  • Ensured regulatory compliance through continuous trial oversight, leading to 16 site audits with 22% successful outcomes.

Affiliations

  • Jaycees
  • Association for Women in Science (AWIS)
  • Society for Clinical Trials (SCT)
  • Rotary International
  • American Medical Informatics Association
  • Lead Research Participant, procedure Clinical Trials Day Event (2021)
  • Member, Health Research Authority's (HRA) Clinical Research Network
  • Clinical Research Training Network (CRTN)
  • Collaborator on category at Summit Group
  • Society of Clinical Research Associates (SOCRA)

Certifications

  • Electronic Data Capture (EDC) System Certificate – program, (2016)
  • Certified Public Accountant
  • Certified Clinical Research Associate (CCRA) - Association of Clinical Research Professionals (ACRP), 2024
  • Medical Device Regulation (MDR) Training Certificate – process, (2016)
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Bloodborne Pathogens Training – OSHA 2023
  • Basic Life Support (BLS) Certification - American Heart Association 2023
  • Human Subjects Research (HSR) Certification - Collaborative Institutional Training Initiative (CITI Program) - 2019
  • Clinical Data Management Specialist Certification – Society for Clinical Data Management (SCDM), (2016)
  • Health Insurance Portability and Accountability Act (HIPAA) Certification - Ironclad Systems, 2015

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