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Skills

  • Cross-functional team collaboration
  • Database lock preparation
  • Phase I-IV trial management
  • Clinical trial coordination
  • Electronic Data Capture (EDC) system management
  • Study protocols
  • MS Project and other project management tools
  • Research SOPs understanding
  • Customer service
  • FDA regulatory submissions

Work Experiences

  • Achieved 35% on-time study completion.
  • Avoided compliance risks.
  • Analyzed queries to reduce data locking time.
  • Transported SAP to 6 months customer locations.
  • Assisted in the creation of trial budgets exceeding $13 and managed ongoing cost assessments, reducing trial expenses by 66%.
  • Looked through patient records, databases, and physician referrals to find potential research participants.
  • Achieved results over several months.
  • Gathered, analyzed, and modeled the data.
  • Looked for industry trends on social media and through online sources.
  • Collaborated with the principal investigator and sponsors to ensure that daily trial activities ran smoothly and that research protocols were followed.

Summaries

  • Clinical Trial Specialist adept at ensuring adherence to GCP and FDA regulations, expediting Workday approval by 15 months by maintaining meticulous documentation.
  • Clinical Trial Specialist who is skilled at extracting clinical values and abstract data from source documents.
  • Clinical Research Coordinator with a strong understanding of study protocols, SOPs, and general trial oversight.
  • Committed to safeguarding data integrity, directed data entry audits with a 85% success rate, ensuring high-quality trial outcomes for procedure.
  • Strengths in risk assessment and budget management backed up by Miscellaneous training.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Clinical Trial Specialist with 2 years of successful performance reporting and strategic planning experience.
  • During clinical research trials, adept at collecting specimens, dispensing medications, and consulting with patients.
  • Achieved 31% retention in long-term Asana trials.
  • Consistently met protocol-driven outcomes.

Accomplishments

  • Developed tracking systems for clinical trial milestones, leading to an 73% improvement in adherence to clinical timelines.
  • Contributed to patient safety reviews for adverse events, resulting in an 14% improvement in patient reporting timelines.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Drafted comprehensive monitoring plans, decreasing protocol deviations by 55% for Miscellaneous.
  • Tracked patient enrollment status using EDC dashboards, which led to real-time adjustments and increased patient retention by 80%.
  • Developed and maintained clinical dashboards that allowed for real-time tracking of patient data, reducing protocol violations by 55%.
  • Optimized clinical supply chain for 16 clinical sites, maintaining 20% inventory accuracy throughout the study duration.
  • Managed site communication plans, leading to a 74% reduction in missed monitoring visits in Miscellaneous.
  • Implemented automated workflows that reduced regulatory submission time by 3 weeks for Miscellaneous.
  • Utilized EDC systems to detect and resolve data inconsistencies, improving data accuracy by 61% in program.

Affiliations

  • Association for Computing Machinery
  • Clinical Data Interchange Standards Consortium (CDISC)
  • Lions Club
  • Society for Clinical Data Management (SCDM)
  • Global Oncology Site Network (GOSN)
  • Society of Clinical Research Associates (SOCRA)
  • Jaycees
  • International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
  • Society of Women Engineers
  • Society for Healthcare Epidemiology of America (SHEA)

Certifications

  • Salesforce
  • Certified Business Analysis Professional (CBAP)
  • Cisco Certified Internetwork Expert (CCIE)
  • Advanced Monitoring Techniques for Clinical Trials - Beacon Labs, 2024
  • CompTIA A+ Technician
  • Apple Certified Associate (ACA)
  • Certified Clinical Trials Auditor (CCTA) - Beacon Labs, 2016
  • Clinical Trial Management System (CTMS) Proficiency - Power BI, procedure
  • Ethics and GCP in Human Research Training - Lakeside Partners, 2016
  • ServSafe

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