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Skills

  • Good Clinical Practices
  • Effective agenda preparation and minute taking
  • Budgets
  • Protocol Compliance Monitoring
  • Cross-functional team collaboration
  • Process improvement
  • Research SOPs understanding
  • Trial management
  • Informed consent
  • Continuous process improvement in clinical settings

Work Experiences

  • Achieved a 28% increase in satisfaction scores.
  • Was in charge of collecting, processing, and shipping lab specimens.
  • Advanced adherence to project timelines.
  • Looked through patient records, databases, and physician referrals to find potential research participants.
  • Collaborated with cross-functional teams to manage timelines and deliverables for Adobe Creative Suite trials in Columbus, facilitating on-time completion.
  • Assisted with financial disclosure forms and contracts with vendors, reducing administration bottlenecks and approving expenses faster than projected.
  • Gathered, analyzed, and modeled the data.
  • Oversaw the delivery of system project by program team, which resulted in procedure.
  • Kept track of the unit budget to ensure that the spend rate and funding targets were met.
  • Saved $10 by putting in place cost-cutting measures that addressed long-standing issues.

Summaries

  • Clinical Trial Assistant with an analytical mindset.
  • Ready to apply 12 years of related experience to a new role that will test me.
  • Collaborated with investigational sites and CRAs.
  • Strategic planning is certified.
  • Clinical Trial Assistant with a proven ability to manage the logistics of investigational products, decreasing delivery delays and improving site readiness by 26%.
  • Collaborated with cross-functional teams.
  • Clinical Trial Assistant with proven logistics management skills.
  • Dedicated to learning, growing, and succeeding in Healthcare.
  • Analytical skills are applied to identify data or patient safety concerns.
  • Clinical Trial Assistant with a proven track record of improving trial material readiness across 14 locations, ensuring smooth trial operations and on-time deliveries.

Accomplishments

  • Led the preparation for routine sponsor and regulatory authority monitoring visits, contributing to zero major findings during an FDA site inspection.
  • Regularly assisted in managing patient enrollment and retention tracking, maintaining 83% patient retention across 4 clinical sites.
  • Collaborated with team of 13 in the development of system.
  • Tracked and documented study supplies, including investigational product movement and accountability, complying with all FDA and EMA requirements.
  • Partnered with data management teams to reconcile adverse event logs, ensuring compliance with all safety reporting requirements and reducing data discrepancies.
  • Presented trial data trends and progress updates to senior management, leading to 15 actionable recommendations that streamlined trial processes.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Supported protocol amendments and regulatory submissions by preparing documentation and regulatory binders, ensuring compliant submissions across 16 sites.
  • Documented and resolved initiative which led to metric.
  • Scheduled and tracked essential trial meetings, distributing agendas and documenting actionable items, ensuring key outcomes were delivered on time.

Affiliations

  • Project Management Institute
  • Healthcare Information and Management Systems Society (HIMSS)
  • American Medical Informatics Association
  • Clinical Data Interchange Standards Consortium (CDISC)
  • National Association of Clinical Research Professionals (NACRP)
  • National Association of Social Workers
  • American Marketing Association
  • International Association of Administrative Professionals
  • Association for the Accreditation of Human Research Protection Programs (AAHRPP) Membership
  • Institute of Clinical Research (ICR) – Professional Development Program

Certifications

  • Good Clinical Practice (GCP) Certification
  • Cisco Certified Internetwork Expert (CCIE)
  • CITI (Collaborative Institutional Training Initiative) Human Subjects Research Certification
  • Salesforce
  • CompTIA Security+
  • Certified Public Accountant
  • EMEA (European Medicines Agency) Regulatory Certification
  • ICH-GCP (International Conference on Harmonization - Good Clinical Practice) Certification
  • Cisco Certified Network Associate (CCNA)
  • Certified Clinical Research Coordinator (CCRC)

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