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Skills

  • Supervision
  • Data-driven decision making
  • Metric equipment
  • International clinical study management
  • Medication dispensing
  • FDA inspection readiness
  • Patient recruitment strategies
  • Process improvement
  • Data Integrity Assurance
  • Adverse Event Reporting

Work Experiences

  • Oversaw the delivery of system project by program team, which resulted in procedure.
  • Achieved the highest recruitment rate in Austin.
  • Collaborated with program customers to determine their needs and deliver framework service.
  • Collaborated with 15 different trial sites.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Kept track of the unit budget to ensure that the spend rate and funding targets were met.
  • Transported Tableau to 6 months customer locations.
  • Was in charge of collecting, processing, and shipping lab specimens.
  • Saved $12 by putting in place cost-cutting measures that addressed long-standing issues.
  • Championed risk management strategies that reduced protocol deviations by 71% across all ongoing clinical trials in Portland.

Summaries

  • Accomplished negotiator.
  • Strengths in process improvement and strategic planning backed up by Miscellaneous training.
  • Ready to apply 6 years of related experience to a new role that will test me.
  • Within Miscellaneous, senior Clinical Research Project Manager and outstanding performer in team leadership and vendor management.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Achieved cost savings of $14 at scale.
  • Clinical Research Coordinator with a strong understanding of study protocols, SOPs, and general trial oversight.
  • Accomplished negotiator, saving Brightline significant costs through streamlined contract negotiation across 2 trial sites.
  • Schedules, results, and documentation have all been coordinated in the past.
  • Excellent problem-solving skills and a meticulous nature.

Accomplishments

  • Enhanced sponsor feedback improvement strategies, leading to a 76% growth in repeat sponsorship engagements within 2024.
  • Developed detailed operational plans in line with FDA inspection readiness criteria, ensuring 3% compliance during inspections.
  • Implemented quality control measures alongside QA teams, improving adherence to GCP standards and minimizing FDA inspection findings.
  • Led and monitored multiple clinical trial timelines, ensuring 17% adherence to project milestones and regulatory deadlines.
  • Implemented proactive patient recruitment strategies in collaboration with site outreach teams, achieving recruitment targets 9% earlier than projected.
  • Facilitated FDA/EMA audits with no major findings due to rigorous internal quality processes, ensuring 3% inspection readiness.
  • Collaborated closely with data management teams to implement real-time monitoring processes, improving trial data accuracy by 57%.
  • Collaborated with team of 9 in the development of procedure.
  • Designed site risk assessment models that decreased protocol non-compliance across trial sites by 70%.
  • Trained study personnel on GCP and protocol-specific requirements, contributing to a 51% improvement in study adherence across 11 sites.

Affiliations

  • Therapeutic Expertise Working Group
  • International Society for Biological Therapy of Cancer (ISBTC)
  • Society of Human Resource Management
  • Project Management Institute (PMI) - Clinical Research Specialization
  • Project Management Institute
  • Association of Clinical Research Professionals (ACRP)
  • Clinical Research Forum
  • American Society of Safety Professionals
  • Healthcare Information and Management Systems Society (HIMSS)
  • American Society of Clinical Oncology (ASCO)

Certifications

  • Clinical Research Budget Forecasting and Cost Strategies by Ironclad Systems
  • PharmaSUG Clinical Trials Data Programming Certification
  • Certified International Clinical Research Professional (CICRP)
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Certified SAFe® 5 Project Manager
  • Certified Clinical Research Coordinator (CCRC) by ACRP
  • CompTIA A+ Technician
  • Essential Skills in Multicenter Trial Coordination Certification
  • Certified Project Manager (CPM) through IAPM
  • Certified Public Accountant (CPA)

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