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Skills

  • Relationship development
  • Communications
  • Mitigating study data discrepancies
  • Operational improvement
  • Trial management
  • Business operations
  • Creating patient-friendly communication materials
  • Medication dispensing
  • Lab equipment calibration
  • Advanced proficiency in category

Work Experiences

  • Achieved goals several months earlier than expected.
  • Looked for industry trends on social media and through online sources.
  • Clinical trials for disorders like procedure and metric were coordinated by me.
  • Collaborated with external sponsors and CROs to resolve initiative in trial execution, safeguarding the integrity of metric and maintaining study timelines.
  • Assisted with writing informed consent documents.
  • Assisted with writing and editing informed consent documents for multi-center trials, improving patient comprehension and increasing consent rates by 68%.
  • Collected and processed over 6 biological samples.
  • Assisted in preparing regulatory submissions to the FDA.
  • Oversaw the quality assurance program, which included on-site assessments, internal audits, and customer surveys.
  • Transported Jira to 18 months customer locations.

Summaries

  • Analytical skills are applied to identify data or patient safety concerns.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Exceptionally well-organized and thorough, with excellent planning and problem-solving skills.
  • Adhered to FDA regulatory frameworks.
  • Clinical Research Technician proficient in detailed documentation.
  • Achieved successful study outcomes.
  • Clinical Research Technician who is skilled at extracting clinical values and abstract data from source documents.
  • Recognized on a regular basis for outstanding performance and contributions to the Healthcare industry's success.
  • Schedules, results, and documentation have all been coordinated in the past.
  • Clinical Research Technician proficient in detailed documentation and compliance using Asana, ensuring all clinical trial data was managed efficiently and within FDA regulatory frameworks.

Accomplishments

  • Monitored adverse event reports and ensured data was accurately reported in compliance with FDA and GCP guidelines, minimizing protocol deviations.
  • Managed documentation and communication with the Institutional Review Board (IRB) for 9 approved protocols, ensuring accurate reporting.
  • Contributed to protocol reviews and recommended changes that increased patient compliance by 74% during the Healthcare trial.
  • Participated in closing out Healthcare trials, finalizing data and ensuring all deliverables were submitted to meet sponsor deadlines.
  • Documented and resolved category which led to process.
  • Reduced time spent on manual documentation entry by implementing an automated EDC system, achieving 64% greater efficiency.
  • Improved patient scheduling efficiency by integrating ServiceNow into daily operations, resulting in a 39% reduction in appointment conflicts.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Conducted weekly site monitoring visits, identifying potential compliance issues early and resolving them before audit findings.
  • Introduced a new SOP for coordinating study-related shipments, reducing delays and improving shipping efficiency by 21%.

Affiliations

  • International Clinical Research Training Institute (ICRTI)
  • Association of Information Technology Professionals
  • Society for Clinical and Translational Science (SCTS)
  • Society for Clinical Trials (SCT)
  • International Council of Nurses
  • International Society for Clinical Biostatistics (ISCB)
  • American Heart Association Council on Epidemiology and Prevention
  • Toastmasters
  • Biomedical Engineering Society (BMES)
  • American Medical Informatics Association (AMIA)

Certifications

  • CompTIA Network+
  • Society of Clinical Research Associates (SoCRA) Clinical Research Professional (CCRP) Certification
  • Institutional Review Board (IRB) Training Certificate - Boston
  • Google Certified Professional Cloud Architect
  • Certified Medical Laboratory Technician (MLT) - ASCP
  • Human Subjects Research (HSR) Certification - Brightline
  • Clinical Data Management Certification - Brightline
  • Cisco Certified Network Associate (CCNA)
  • Certified Business Analysis Professional (CBAP)
  • National Healthcareer Association – Certified Clinical Medical Assistant (CCMA)

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