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Skills

  • Regulatory compliance
  • Patient retention and adherence improvement
  • Private investigation laws
  • Grant proposal writing
  • Searches
  • Pharmacovigilance
  • Team building
  • Insurance claims cases
  • Business operations
  • Patient recruitment strategy

Work Experiences

  • Contributed to the publication of 16 peer-reviewed articles.
  • Collaborated with biostatisticians to refine interim data analyses, resulting in early submission of Tableau to the initiative.
  • Solved procedure issues, improved operations, and provided excellent customer service.
  • Looked for industry trends on social media and through online sources.
  • Authored standard operating procedures for harmonizing patient safety reports, reducing adverse event response times by 59%.
  • Approved critically-needed trials within 18 months.
  • Cut attrition rates by 25%.
  • Collaborated with metric customers to determine their needs and deliver system service.
  • Collaborated with regulatory agencies to ensure trial compliance, reducing audit findings by 70%.
  • Authored standard operating procedures.

Summaries

  • Clinical Investigator with expertise in patient recruitment strategies.
  • Accomplished Clinical Investigator with hands-on experience in managing multi-site trials across Boston, reducing dropout rates by 67% and delivering FDA-approved products.
  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.
  • Achieved 16 successful study completions.
  • Contributed to Excellence Award in 2016.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the system business.
  • Clinical Investigator with experience in patient safety monitoring.
  • Achieved 37% enrollment increases.
  • Clinical Investigator with deep expertise in coordinating cross-functional teams. Successfully facilitated meetings, achieving milestone completions 14 weeks ahead of schedule.
  • Adept in risk management.

Accomplishments

  • Created study documentation using Workday, leading to a 66% reduction in regulatory audit findings during 2017.
  • Introduced a new audit preparedness process, reducing non-compliance findings during regulatory inspections by 30% % in 2016.
  • Implemented electronic data capture (EDC) systems across 15 clinical sites, yielding a 78% increase in data accuracy and collection efficiency.
  • Spearheaded protocol amendments, reducing investigational product time-to-market by 16 months while maintaining safety and efficacy.
  • Served as key liaison between clinical operations and regulatory affairs, ensuring all clinical trials met global regulatory requirements.
  • Managed data review meetings for cross-functional teams, identifying and resolving data discrepancies faster, thus improving the overall study timeline.
  • Optimized study protocol and patient consent processes, reducing participant dropout rates by 31% and improving study completion rates.
  • Led efforts in securing PMP, enhancing the company’s compliance and standing with global regulatory bodies.
  • Led clinical data reviews, discovering data anomalies and reducing data entry errors by 76% % through multiple audits and oversight improvements.
  • Supervised clinical data reconciliation efforts, ensuring faster resolution of data discrepancies and improving data quality by 69% %.

Affiliations

  • Collaborative Institutional Training Initiative (CITI Program)
  • Applied Clinical Trials Editorial Advisory Board Member
  • Project Management Institute
  • American College of Epidemiology (ACE)
  • Society of Women Engineers
  • Toastmasters
  • World Association of Medical Editors (WAME)
  • International Council of Nurses
  • Society of Human Resource Management
  • AcademyHealth

Certifications

  • Certified Public Accountant
  • Principles and Practice of Clinical Research Certification – Harvard T.H. Chan School of Public Health
  • Certified Investigator Training Program – Public Responsibility in Medicine and Research (PRIM&R)
  • Certified Professional in Regulatory Affairs (RAC) - Regulatory Affairs Professionals Society (RAPS)
  • Certified Principal Investigator (CPI) - Association of Clinical Research Professionals (ACRP)
  • ICH E6(R2) Good Clinical Practice Certification – Northwind
  • Clinical Investigator Training Program – U.S. Food and Drug Administration (FDA)
  • Basic Life Support (BLS) Certification – American Heart Association
  • Google Certified Professional Cloud Architect
  • Cisco Certified Internetwork Expert (CCIE)

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