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Skills

  • Corrective and preventive actions (CAPA) initiation
  • Specimen collections
  • Study protocols
  • Medical writing and documentation
  • Communications
  • Research SOPs understanding
  • Operational improvement
  • Budgets
  • MS Office
  • Good Clinical Practices

Work Experiences

  • Assessed trials spanning 12 locations.
  • Gathered, analyzed, and modeled the data.
  • Collaborated with the data management team to resolve discrepancies, leading to a 40% error reduction in case report forms.
  • Conducted site feasibility assessments.
  • Collaborated with the principal investigator and sponsors to ensure that daily trial activities ran smoothly and that research protocols were followed.
  • Achieved a 47% faster enrollment rate.
  • Had an excellent attendance record and was always on time for work.
  • Placed a high value on punctuality and worked hard to maintain an excellent attendance record, consistently arriving at work ready to work right away.
  • Ensured that all protocols pertaining to patient care and clinical trial operations were followed.
  • Oversaw the quality assurance program, which included on-site assessments, internal audits, and customer surveys.

Summaries

  • Achieved 52% faster patient enrollment.
  • Within Miscellaneous, senior Senior Clinical Trial Coordinator and outstanding performer in budget management and team leadership.
  • Achieved faster enrollment rates in complex Workday trials.
  • 18 years of experience in vendor management.
  • Achieved a 31% reduction in protocol deviations.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Budget management is certified.
  • Senior Clinical Trial Coordinator is a multi-talented Senior Clinical Trial Coordinator who is consistently rewarded for planning and operational improvements.
  • Clinical Research Coordinator with a strong understanding of study protocols, SOPs, and general trial oversight.

Accomplishments

  • Delivered clinical trial status updates to 18 key stakeholders, improving project visibility and transparency.
  • Onboarded and managed relationships with new CRO vendors, reducing trial outsourcing costs by 58%.
  • Coordinated with CROs and vendors across international sites, ensuring consistent communication and adherence to local regulations.
  • Oversaw vendor selection and contract negotiations, saving 51% in trial-related expenses.
  • Utilized eTMF systems for trial documentation, reducing document retrieval time by 67% and ensuring regulatory readiness.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Managed the ethical submission process for 7 studies, achieving successful approvals within standard days of submission.
  • Implemented budget monitoring systems, reducing trial operating costs by 52% over the course of 6 months.
  • Developed and streamlined clinical trial processes, resulting in a 18% reduction in trial delays.
  • Led 14 internal and external audits, achieving zero critical findings across all sites.

Affiliations

  • Society for Clinical Trials (SCT)
  • Association for Computing Machinery
  • TransCelerate BioPharma Membership
  • International Association of Administrative Professionals
  • EMA Clinical Research Initiative Working Group
  • Clinical Data Interchange Standards Consortium (CDISC)
  • Society of Behavioral Medicine - Clinical Trials Unit Special Interest Group
  • International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
  • Association of Information Technology Professionals
  • Association of Clinical Research Professionals (ACRP)

Certifications

  • Certified Public Accountant (CPA)
  • Google Certified Professional Cloud Architect
  • Certified Clinical Data Manager (CCDM) by Society for Clinical Data Management (SCDM)
  • ServSafe
  • Human Subjects Protection Training Certificate by NIH
  • Health Informatics Certificate by Lakeside Partners
  • ICH Good Clinical Practice E6 (R2) Certification by Vantage
  • Cisco Certified Network Associate (CCNA)
  • Certified Business Analysis Professional (CBAP)
  • Clinical Site Monitoring Certificate from Vantage

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