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Skills

  • Clinical trial regulatory submissions
  • Adverse event monitoring and reporting
  • On-site monitoring and visit facilitation
  • Ethics Committee/IRB submissions
  • Regulatory compliance
  • Research SOPs understanding
  • Framework equipment
  • Interdisciplinary coordination of care
  • Ethical considerations in clinical research
  • Supervision

Work Experiences

  • Gathered, analyzed, and modeled the data.
  • Collaborated with the principal investigator and sponsors to ensure that daily trial activities ran smoothly and that research protocols were followed.
  • Collaborated with bioinformatics experts to integrate genetic data, contributing to personalized treatment protocols and improving outcomes for 7 patients.
  • Contributed to the development and testing of innovative medical devices, with study outcomes leading to 14 successful FDA approvals.
  • Looked for industry trends on social media and through online sources.
  • Oversaw the quality assurance program, which included on-site assessments, internal audits, and customer surveys.
  • Contributed to personalized treatment protocols.
  • Achieved a resolution rate of 46%.
  • Analyzed and interpreted lab results.
  • Collaborated with multidisciplinary teams.

Summaries

  • Costs were consistently reduced while profits were increased.
  • Collaborated with pharmaceutical sponsors.
  • Administered $17 in trial funding.
  • Adept at managing multi-site clinical trials.
  • Achieved results over a three years period.
  • Exceptionally well-organized and thorough, with excellent planning and problem-solving skills.
  • Ready to apply 4 years of related experience to a new role that will test me.
  • Adept at authoring high-quality study documents, including informed consent forms and study manuals, enhancing participant comprehension and increasing enrollment rates by 39%.
  • Aligned outcomes with sponsor requirements.
  • Contributed to the success of 2 peer-reviewed publications.

Accomplishments

  • Received PMP to improve clinical trial monitoring processes and enhance patient safety protocols.
  • Implemented patient recruitment strategy that shortened enrollment time by 73% for 14 clinical trials.
  • Contributed to the development of clinical trial education materials, improving team preparedness and patient compliance across 14 studies.
  • Led a cross-functional team to resolve data discrepancies, resulting in a 66% improvement in data accuracy for trial submissions.
  • Authored and published 8 peer-reviewed articles in leading medical journals, showcasing trial results and methodologies.
  • Established a system for tracking adverse events, improving reporting compliance by 29% and reducing time to resolution by 14 days.
  • Collaborated with team of 2 in the development of process.
  • Resolved product issue through consumer testing.
  • Developed and maintained a comprehensive database tracking protocols and informed consents for 6 active clinical trials.
  • Reduced trial protocol deviations by 28% through targeted staff training and enhanced monitoring techniques.

Affiliations

  • Society of Women Engineers
  • Nursing Research Interest Group – Illinois Nursing Association, 2022
  • Council on Surgical and Perioperative Safety (CSPS) – Research Involvement, 2019
  • American Association of Nurse Practitioners (AANP) 2015
  • Public Responsibility in Medicine and Research (PRIM&R) 2024
  • Regulatory Affairs Professionals Society (RAPS) – Clinical Trials Focus, CPA
  • Healthcare Information and Management Systems Society (HIMSS), procedure
  • Society for Clinical Trials (SCT) Affiliate, 2021
  • Global Oncology Nursing Society – Research Nurse Group, 2022
  • National Association of Social Workers

Certifications

  • Certified Nurse Educator (CNE) - method
  • Certified in Healthcare Research Compliance (CHRC) – HCCA
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Certified Clinical Research Professional (CCRP) – SOCRA
  • Fundamentals of Global Clinical Trials - program
  • First Aid/CPR Certified
  • Certified Research Administrator (CRA) - Research Administrators Certification Council (RACC)
  • Regulatory Affairs Certification (RAC) - Regulatory Affairs Professionals Society
  • Clinical Research Project Management Certificate - Ironclad Systems
  • Google Certified Professional Cloud Architect

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