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Skills

  • Clinical trial coordination
  • Team management
  • Ethics committee submissions
  • Project organization
  • Medication dispensing
  • Clinical staff training programs
  • Communications
  • Budgets
  • Experiment and protocol adherence
  • Mentoring and training junior staff

Work Experiences

  • Assisted in protocol development.
  • Authored and presented clinical research findings to key stakeholders, resulting in the adoption of trial recommendations by multiple sites worldwide.
  • Achieved Outstanding Service Award for excellence in clinical trial management in 2021.
  • Gathered, analyzed, and modeled the data.
  • Oversaw the delivery of method project by system team, which resulted in process.
  • Pushed for operational changes that resulted in cost savings and higher profit margins.
  • Based recommendations on current analysis.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Achieved faster regulatory submissions.
  • Solved metric issues, improved operations, and provided excellent customer service.

Summaries

  • Collaborated with external vendors.
  • Clinical Research Specialist with 17 years of successful process improvement and project management experience.
  • Clinical Research Coordinator with a strong understanding of study protocols, SOPs, and general trial oversight.
  • Conducted data analysis to ensure compliance.
  • During clinical research trials, adept at collecting specimens, dispensing medications, and consulting with patients.
  • Clinical Research Specialist with extensive experience.
  • Achieved 74% protocol compliance.
  • Costs were consistently reduced while profits were increased.
  • Adept at developing study protocols.
  • Clinical Research Specialist committed to data integrity, with experience reviewing source documents for 16 participant cohorts and achieving a 82% reduction in protocol violations.

Accomplishments

  • Collaborated with site coordinators to facilitate patient randomization, resulting in 38% increase in recruitment over three years.
  • Supervised collection and validation of patient-reported outcomes, resulting in 12 abstracts and presentations at method.
  • Authored patient materials and informed consent documents, complying with local and global regulations while improving patient comprehension by 20%.
  • Drafted and refined informed consent forms for use in 9 trials, enhancing patient understanding and reducing consent-related queries by 81%.
  • Created data analysis plans and resolved data inconsistencies, reducing database lock time by 64% in two years.
  • Authored and reviewed clinical protocols for method, ensuring compliance with GCP and ICH guidelines.
  • Monitored and analyzed patient-reported outcome data, which informed ongoing modifications to clinical protocols for enhanced efficacy.
  • Monitored and reported on patient safety data for phase 10 trials in initiative, resulting in 25% fewer SAE reports filed out of time window.
  • Documented and resolved standard which led to initiative.
  • Resolved 8 data queries related to standard across 15 phases, ensuring trial integrity and regulatory compliance.

Affiliations

  • Health Informatics Research Organization (HIRO) Membership 2016
  • Society for Clinical Trials (SCT) Editorial Board Contributor 2022
  • American Marketing Association
  • International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Member 2022
  • Good Clinical Practice (GCP) Certification awarded by procedure 2019
  • Leadership in Clinical Innovation Roundtable in Columbus 2018
  • Toastmasters
  • Member of the Clinical Research Society (CRS) 2021
  • Member, European Society for Clinical Research (ESCR) since 2016
  • American Society of Safety Professionals

Certifications

  • Advanced Good Clinical Practice (GCP) Compliance Certification by Beacon Labs
  • Basic Life Support (BLS) Certification by AHA
  • Certified Clinical Research Professional (CCRP) by SOCRA
  • Apple Certified Associate (ACA)
  • Cisco Certified Network Associate (CCNA)
  • Principles of Clinical Pharmacology Certification by NIH
  • Certified TransCelerate Clinical Trial Investigator
  • Advanced Regulatory Affairs Certificate by RAPS 2024
  • Project Management Professional (PMP)
  • Pharmacovigilance and Drug Safety Certification

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