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Skills

  • Supervision
  • Business operations
  • First Aid/CPR
  • Risk assessment and mitigation
  • Ethics Committee/IRB preparation
  • Cross-functional collaboration with R&D
  • Team management
  • Research SOPs understanding
  • Budget management for clinical trials
  • Medication dispensing

Work Experiences

  • Championed patient-centered clinical trial designs.
  • Built relationships with KOLs (Key Opinion Leaders).
  • Was in charge of collecting, processing, and shipping lab specimens.
  • Collaborated with cross-functional teams.
  • Looked for industry trends on social media and through online sources.
  • Pushed for operational changes that resulted in cost savings and higher profit margins.
  • Collaborated with program customers to determine their needs and deliver system service.
  • Achieved FDA approval for QuickBooks in 2018.
  • Achieved a 58% decrease in protocol amendments.
  • Achieved Top Performer recognition for clinical excellence.

Summaries

  • Collaborated across departments to cut study durations by 34%.
  • Director of Clinical Affairs who is skilled at extracting clinical values and abstract data from source documents.
  • Exceptionally well-organized and thorough, with excellent planning and problem-solving skills.
  • Approved clinical study reports (CSRs).
  • Adopted innovative patient recruitment techniques.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the category business.
  • Committed to driving operational excellence.
  • Achieved accelerated approvals.
  • Excellent problem-solving skills and a meticulous nature.
  • Achieved a 20% decline in adverse event reporting.

Accomplishments

  • Enhanced clinical trial patient enrollment by 65% using targeted engagement and communication strategies, improving overall trial power and success rates.
  • Optimized data flow processes, reducing overall data collection timeframe in phase III trials by 4%, aligning with projected budget constraints.
  • Played a key role in responding to regulatory inquiries across Chicago, ensuring all clinical documentation adhered to worldwide compliance standards, resulting in the successful commercial launch of HubSpot.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Authored 7 clinical development plans and successfully aligned objectives with corporate regulatory strategies, leading to a 39% faster project approval timeline.
  • Directed risk management initiatives that reduced adverse event reporting timelines by 53% in compliance with FDA and EMA standards.
  • Played an integral role in the successful launching of SAP clinical trials within 11 months by cross-collaborating with research, quality, and operations teams.
  • Collaborated with team of 2 in the development of framework.
  • Developed and implemented strategic clinical team training focused on adverse event reporting, decreasing the query response times by 54%.
  • Led post-market clinical surveillance programs for HubSpot, resulting in the identification and correction of potential issues, improving patient safety metrics by 83%.

Affiliations

  • Fellow, Clinical and Translational Science Institute (CTSI) 2015
  • Rotary International
  • American Medical Writers Association (AMWA)
  • Member, Agile Alliance with Clinical Trials Focus
  • International Association of Clinical Research Nurses (IACRN)
  • Lions Club
  • Association of Clinical Research Organizations (ACRO)
  • American Medical Informatics Association
  • Affiliate Member, National Institute of Health Research (NIHR) Phoenix
  • Academy of Clinical Research Professionals (ACRP)

Certifications

  • First Aid/CPR Certified
  • Cisco Certified Internetwork Expert (CCIE)
  • Healthcare Leadership Academy Certification in Clinical Research Management by framework
  • SHRM Certified Professional (SHRM-CP)
  • Cisco Certified Network Associate (CCNA)
  • CompTIA A+ Technician
  • Certified International Healthcare Compliance Professional (CIHCP) from Meridian
  • Risk Assessment for Medical Device Trials Certificate by Lakeside Partners
  • Certified Risk Management Professional in Clinical Innovation (CRMP-CI) from the Risk Management Association
  • Change Management Certification by Prosci

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