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Skills

  • Specimen collections
  • Study protocols
  • Informed consent process
  • Supervision
  • Medication dispensing
  • Clinical trial logistics optimization
  • Team building
  • Informed consent
  • Clinical research associate (CRA) oversight
  • First Aid/CPR

Work Experiences

  • Authored and maintained standard operating procedure (SOP) documentation for managing adverse events, reducing reporting errors by 75%.
  • Was in charge of collecting, processing, and shipping lab specimens.
  • Achieved results within the past year.
  • Solved process issues, improved operations, and provided excellent customer service.
  • Assisted in coordinating safety reporting entries.
  • Achieved timely updates.
  • Achieved cost savings of $12 across 2019.
  • Addressed site recruitment concerns.
  • Adhered to cost frameworks.
  • Authored standard operating procedure (SOP) documentation.

Summaries

  • Clinical Trial Associate who is skilled at extracting clinical values and abstract data from source documents.
  • Capable of driving protocol execution through vigilant quality assurance processes, eliminating documentation errors by 17% in Miscellaneous trial.
  • Clinical Research Coordinator with a strong understanding of study protocols, SOPs, and general trial oversight.
  • Achieved a 26% reduction in protocol deviations.
  • Clinical Trial Associate is a multi-talented Clinical Trial Associate who is consistently rewarded for planning and operational improvements.
  • Dedicated to learning, growing, and succeeding in Miscellaneous.
  • Ready to apply 11 years of related experience to a new role that will test me.
  • Costs were consistently reduced while profits were increased.
  • Ahead of critical milestones.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the metric business.

Accomplishments

  • Managed third-party vendors for Miscellaneous, ensuring timely delivery of services and reducing operational costs by 41%.
  • Implemented improvements in data collection methods, reducing data entry errors by 71% and increasing overall data quality across Miscellaneous.
  • Generated site payment reports in CTMS and collaborated with finance teams, reducing discrepancies in compensation by 40% within 6 months.
  • Created a project management dashboard in SAP, improving deliverable tracking and resource allocation for multi-national clinical trials.
  • Collaborated with the clinical operations team to facilitate trial closeout activities, ensuring all tasks were completed by program, ahead of schedule by 16 days.
  • Enhanced patient recruitment outreach campaigns, increasing trial enrollment by 84% using targeted communication strategies in program.
  • Coordinated the preparation and submission of trial master files (TMF), maintaining 28% regulatory compliance throughout Miscellaneous, resulting in 18 audit findings.
  • Coordinated cross-functional meetings between clinical research, regulatory, and data management teams, improving collaboration and reducing trial timeline risks by 83%.
  • Managed budget forecasts for Miscellaneous, reconciling cost overruns and improving financial reporting accuracy by 67%.
  • Monitored SAP clinical trial progress through CTMS, ensuring all milestones were met within agreed timelines and ahead of method deadlines.

Affiliations

  • Association of Biopharmaceutical Industry Clinical Operations
  • Association of Medical Research Charities (AMRC)
  • American Medical Informatics Association
  • Society of Clinical Research Associates (SOCRA)
  • Clinical Research Management and Compliance Forum
  • International Network for Privacy Law Professionals in Clinical Trials (INPLPCT)
  • Freemason
  • European Union Clinical Trial Standards Advisory Committee (EUCTSAC)
  • Regulatory Affairs Certification Board (RACB)
  • International Association of Clinical Research Nurses (IACRN)

Certifications

  • Certified in ISO 14155 for Clinical Investigations - Meridian
  • Advanced Good Clinical Practice (AGCP) – Ironclad Systems
  • EDC Systems (Electronic Data Capture) Certification - Power BI
  • ICH E6(R2) Addendum Workshop Certificate - Northwind
  • Clinical Trials Management Systems (CTMS) Training Certificate - ServiceNow
  • CompTIA A+ Technician
  • Project Management Professional (PMP) - Brightline
  • Google Certified Professional Cloud Architect
  • First Aid/CPR Certified
  • CompTIA Security+

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