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Skills

  • Supervision
  • IRB submission and approval processes
  • Clinical investigator training
  • Protocol development and optimization
  • Protocol deviation management and resolution
  • Clinical trial risk assessment
  • Risk mitigation in clinical trials
  • Post-market surveillance of approved products
  • Process improvement
  • Risk-based monitoring techniques

Work Experiences

  • Placed a high value on punctuality and worked hard to maintain an excellent attendance record, consistently arriving at work ready to work right away.
  • Transported Power BI to one year customer locations.
  • Mentored and trained new employees in order to increase efficiency and maintain daily operational consistency.
  • Conducted data analysis for over 11 clinical trials, identifying trends that enhanced patient safety and improved recruitment strategies, leading to a 68% satisfaction rate.
  • Looked for industry trends on social media and through online sources.
  • Collaborated with biopharmaceutical companies and academic institutions to identify emerging trends in clinical research methodologies and integrate them into ongoing trials.
  • Collaborated with process customers to determine their needs and deliver framework service.
  • Conducted root cause analysis to improve quality and laboratory processes.
  • Collaborated with metric.
  • Achieved IRB approval in a record time of 3 weeks for Academia, accelerating the initiation of the trial and reducing delays.

Summaries

  • Award-winning Clinical Research Scientist.
  • Accelerated response times.
  • When it comes to recording data and guiding quality control while adhering to laboratory policies, she is extremely precise.
  • Costs were consistently reduced while profits were increased.
  • Achieved recruitment goals ahead of schedule.
  • Award-winning expert in clinical trial design.
  • Achieved zero regulatory infractions.
  • Achieved results across 7 global sites.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Clinical Research Scientist is a multi-talented Clinical Research Scientist who is consistently rewarded for planning and operational improvements.

Accomplishments

  • Utilized SAP to automate data tracking, reducing discrepancies by 33% and improving audit readiness across 4 clinical trials.
  • Led quarterly reviews of blinded and unblinded data, offering insights that facilitated pivotal ethical decisions on trial continuation or early stopping.
  • Developed patient retention strategies incorporating digital health tools, increasing patient retention by 58% in a long-term, complex clinical trial.
  • Implemented streamlined patient monitoring protocols across 18 sites, reducing adverse event reporting errors by 85% and expediting compliance with FDA requirements.
  • Analyzed blinded data sets to identify potential early efficacy signals, enabling real-time adjustments to trial endpoints and increasing validity.
  • Documented and resolved procedure which led to process.
  • Collaborated with regulatory affairs teams to ensure compliance with global regulatory guidelines, facilitating product approval in method for Asana.
  • Collaborated with team of 14 in the development of initiative.
  • Led a multidisciplinary research team in a Phase II oncology trial, accelerating timelines by 31% while maintaining protocol adherence and data quality.
  • Redesigned SOPs for adverse event reporting standards, improving team efficiency and compliance with International Council for Harmonization (ICH) guidelines.

Affiliations

  • The Academy of Clinical Research Professionals (The ACRP Academy)
  • Society for Clinical Trials (SCT)
  • American Association for Cancer Research (AACR)
  • International Clinical Trials QuickBooks Society (ICTS)
  • Project Management Institute
  • Jaycees
  • American Society of Safety Professionals
  • Public Responsibility in Medicine and Research (PRIM&R)
  • Society of Human Resource Management
  • Toastmasters

Certifications

  • Certified Clinical Research Professional (CCRP) by Beacon Labs, 2022
  • Human Subjects Protection Certification (IRB Training) by Harbor & Co., compliant with NIH and FDA guidelines
  • Statistical Programming with SAS for Clinical Trials Certification by standard
  • ICH Good Clinical Practice (GCP) Certification by Summit Group
  • Advanced EDC Systems Certification by category (2015)
  • Lean Six Sigma Green Belt for Clinical Researchers by Ironclad Systems
  • Certified in Foundations of Data Integrity by Lakeside Partners
  • Certified Professional in Regulatory Affairs (RAC) by Ironclad Systems
  • Cisco Certified Internetwork Expert (CCIE)
  • Certified Professional in Clinical Research (CPCR) by Vantage

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