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Skills

  • Performance Metrics Tracking
  • Audit Readiness Improvement
  • Stakeholder collaboration
  • Specimen collections
  • Relationship development
  • Regulatory compliance
  • Metric equipment
  • Budgets
  • Decentralized clinical trial design
  • Ethical considerations in clinical research

Work Experiences

  • Achieved a 73% reduction in audit findings.
  • Adopted AI-based patient eligibility screening tools.
  • Authored clinical study reports submitted to the FDA, contributing to the successful approval of Microsoft Excel in 2015.
  • Collaborated with regulatory authorities in Phoenix.
  • Saved $18 by putting in place cost-cutting measures that addressed long-standing issues.
  • Solved initiative issues, improved operations, and provided excellent customer service.
  • Authored clinical study reports.
  • Achieved trial milestones despite geographic challenges.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Achieved Outstanding Service Award for trial excellence.

Summaries

  • Collaborated with cross-functional teams.
  • Dedicated to learning, growing, and succeeding in Healthcare.
  • Patient information, laboratory samples, and compliance documents for a variety of clinical trials are all coordinated by this versatile clinical research professional.
  • Adept at utilizing decentralized clinical trials.
  • Clear understanding of strategic planning and vendor management as well as strategic planning training.
  • Clinical Research Director skilled in developing trial protocols.
  • Achieved a 83% increase in patient recruitment.
  • Achieved faster approvals.
  • Clinical Research Director skilled in developing trial protocols aimed at improving IRB approvals and protocol adherence, streamlining execution timelines.
  • Authored pivotal study reports.

Accomplishments

  • Implemented automated data verification techniques, reducing manual data review steps by 11 days and improving data integrity.
  • Set up and managed SOPs for clinical trial registration on international platforms, reducing time to trial launch by 68%.
  • Led the execution of 16 multi-site Phase III clinical trials, surpassing recruitment goals by 82% and delivering ahead of timeline.
  • Developed data-driven trial site performance scorecards that improved site compliance by 75% and cut costs by 8.
  • Collaborated with regulatory authorities across 15 regions to ensure timely submission and approval of clinical research documentation.
  • Streamlined cross-team communication methodologies, reducing trial cycle times by 80% and improving collaboration across 8 global sites.
  • Formulated risk-based study design workflows that reduced the need for protocol amendments by 83%, enhancing regulatory submission efficiency.
  • Reduced protocol deviations by 74% through focused training sessions and SOP improvements, leading to system for the organization.
  • Conducted root cause analysis on patient dropout rates, driving a 67% improvement in retention for standard studies.
  • Successfully collaborated with 11 cross-disciplinary teams, leading to the accelerated approval of system in 2017.

Affiliations

  • Society for Clinical Trials (SCT)
  • Academy of Physicians in Clinical Research (APCR)
  • Association for Supply Chain Management (APICS)
  • International Society on Thrombosis and Haemostasis (ISTH)
  • American Academy of Neurology (AAN)
  • Association of Clinical and Translational Science (ACTS)
  • American Marketing Association
  • European Organisation for Research and Treatment of Cancer (EORTC)
  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
  • Society of Women Engineers

Certifications

  • Certified Principal Investigator (CPI) - Association of Clinical Research Professionals (ACRP)
  • Advanced Certificate in Clinical Trial Management - program
  • Regulatory Affairs Certification (RAC) - Regulatory Affairs Professionals Society (RAPS)
  • Pharmaceutical and Biotech Clinical Research Certification - DIA (Drug Information Association)
  • CompTIA Network+
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Google Certified Professional Cloud Architect
  • Salesforce
  • ServSafe
  • Human Subjects Protection Program (HSPP) Certification - method

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