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Skills

  • Advanced knowledge of GCP and ICH guidelines
  • Multi-site trial coordination
  • Electronic data capture (EDC) implementation
  • Medical writing collaboration
  • Category equipment
  • Project organization
  • Budget oversight and management
  • Experiment and protocol adherence
  • Contract negotiations with vendors
  • Organization

Work Experiences

  • Looked through patient records, databases, and physician referrals to find potential research participants.
  • Based recommendations on current analysis.
  • Collaborated with procedure customers to determine their needs and deliver program service.
  • Kept track of the unit budget to ensure that the spend rate and funding targets were met.
  • Had an excellent attendance record and was always on time for work.
  • Collaborated in multi-disciplinary teams to design and modify trial protocols that aligned with evolving disease understanding and treatment paradigms.
  • Authored Standard Operating Procedures (SOPs) for clinical data management.
  • Saved $16 by putting in place cost-cutting measures that addressed long-standing issues.
  • Aligned protocols with treatment paradigms.
  • Analyzed adverse event data.

Summaries

  • Clinical Research Specialist who is skilled at extracting clinical values and abstract data from source documents.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the process business.
  • Analytical skills are applied to identify data or patient safety concerns.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Collaborative and detail-oriented researcher with experience working with regulatory authorities to expedite multi-site study initiation, reducing start-up timelines by 49%.
  • Clinical trials leader with comprehensive knowledge of IRB submissions, reducing study start-up delays by 11 weeks, ensuring early trial initiation across multi-site studies.
  • Process improvement is certified.
  • Completed 2 clinical studies on time.
  • Patient information, laboratory samples, and compliance documents for a variety of clinical trials are all coordinated by this versatile clinical research professional.
  • Dedicated to learning, growing, and succeeding in Miscellaneous.

Accomplishments

  • Successfully managed the closeout activities for 18 clinical sites, ensuring all outstanding reconciliation tasks were completed under three years.
  • Improved adverse event reporting process for category studies, reducing average reporting time from 18 months to 6 months.
  • Collaborated with site coordinators to facilitate patient randomization, resulting in 38% increase in recruitment over three years.
  • Created data analysis plans and resolved data inconsistencies, reducing database lock time by 64% in two years.
  • Developed and implemented quality control procedures for data entry, reducing data discrepancies by 16% over three years.
  • Monitored and reported on patient safety data for phase 10 trials in initiative, resulting in 25% fewer SAE reports filed out of time window.
  • Supervised collection and validation of patient-reported outcomes, resulting in 12 abstracts and presentations at method.
  • Monitored and analyzed patient-reported outcome data, which informed ongoing modifications to clinical protocols for enhanced efficacy.
  • Authored and reviewed clinical protocols for method, ensuring compliance with GCP and ICH guidelines.
  • Managed trial master file (TMF) audit preparations, achieving 79% compliance in regulatory compliance review for 2021.

Affiliations

  • Toastmasters
  • Freemason
  • Health Informatics Research Organization (HIRO) Membership 2016
  • International Council of Nurses
  • International Association of Administrative Professionals
  • Member of the Public Responsibility in Medicine and Research (PRIM&R)
  • Member, European Society for Clinical Research (ESCR) since 2016
  • Member of the Applied Clinical Trials Editorial Advisory Board 2021
  • Clinical Research Forum Award recipient for Miscellaneous 2016
  • Association of Clinical Research Professionals (ACRP) - Certified Clinical Research Coordinator (CCRC) 2015

Certifications

  • Biostatistics for Clinical Research Certification by Harbor & Co.
  • Salesforce
  • Microsoft Certified Systems Engineer (MCSE)
  • Clinical Trials Management and Regulatory Compliance Certification
  • FDA Clinical Trials in Accordance with CFR Parts 50, 54, 56, and 312
  • Certified Public Accountant
  • Certified Public Accountant (CPA)
  • FDA Clinical Investigator Training Course
  • CompTIA Security+
  • ServSafe

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