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Skills

  • Project organization
  • Effective Communication with Stakeholders
  • Stakeholder collaboration
  • Team building
  • Clinical study report writing
  • Operational improvement
  • Collaborating with key opinion leaders
  • Trial management
  • First Aid/CPR
  • Cost-reduction strategies in clinical research

Work Experiences

  • Authored clinical study reports.
  • Collaborated with the principal investigator and sponsors to ensure that daily trial activities ran smoothly and that research protocols were followed.
  • Followed informed consent procedures and kept track of everything.
  • Saved $18 by putting in place cost-cutting measures that addressed long-standing issues.
  • Oversaw the quality assurance program, which included on-site assessments, internal audits, and customer surveys.
  • Collaborated with regulatory authorities in Phoenix.
  • Collaborated with biometric specialists.
  • Created a centralized patient registry, improving long-term follow-up capabilities and increasing post-trial data retention by 33%.
  • Achieved trial milestones despite geographic challenges.
  • Created a centralized patient registry.

Summaries

  • Authored pivotal study reports.
  • Adept at utilizing decentralized clinical trials.
  • Achieved 83% fewer discrepancies during audits.
  • Achieved 31% improvement in audit readiness.
  • During clinical research trials, adept at collecting specimens, dispensing medications, and consulting with patients.
  • Collaborated with regulatory authorities.
  • Achieved a 83% increase in patient recruitment.
  • Director of Clinical Research is a multi-talented Director of Clinical Research who is consistently rewarded for planning and operational improvements.
  • Adept at using integrated monitoring strategies.
  • Recognized on a regular basis for outstanding performance and contributions to the Healthcare industry's success.

Accomplishments

  • Resolved product issue through consumer testing.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Integrated real-time patient reporting systems into ongoing trials, resulting in faster adverse event detection—cutting reporting delay by 3 days.
  • Developed remote monitoring strategies and decentralized clinical trial designs, improving data collection speed by 69% and reducing monitoring costs.
  • Managed a cross-functional team of 8 clinical research professionals, ensuring all project milestones were met within 20% of the allocated budget.
  • Led the execution of 16 multi-site Phase III clinical trials, surpassing recruitment goals by 82% and delivering ahead of timeline.
  • Established adaptive trial methodologies that optimized resource use, reducing overall trial costs by 60% and shortening development times.
  • Spearheaded the transition to eConsent systems in 13 trials, simplifying patient onboarding and lifting enrollment rates by 49%.
  • Documented and resolved initiative which led to process.
  • Formulated risk-based study design workflows that reduced the need for protocol amendments by 83%, enhancing regulatory submission efficiency.

Affiliations

  • Association for Computing Machinery
  • Toastmasters
  • Jaycees
  • American Academy of Neurology (AAN)
  • American Society of Clinical Oncology (ASCO)
  • Society for Clinical Data Management (SCDM)
  • International Council of Nurses
  • Society of Toxicology (SOT)
  • American Society of Safety Professionals
  • Society of Human Resource Management

Certifications

  • Certified Clinical Trial Investigator (CCTI) – Association of Clinical Research Professionals (ACRP)
  • Data Standards in Clinical Trials Certification - Vantage
  • Cisco Certified Network Associate (CCNA)
  • Advanced Certificate in Clinical Trial Management - program
  • Project Management Professional (PMP) – Project Management Institute (PMI)
  • Pharmaceutical and Biotech Clinical Research Certification - DIA (Drug Information Association)
  • SHRM Senior Certified Professional (SHRM-SCP)
  • CompTIA Network+
  • Google Certified Professional Cloud Architect
  • ACRP Certified Clinical Research Coordinator (CCRC)

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