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Skills

  • Project timeline management
  • FDA regulatory knowledge
  • Investigator meeting coordination
  • First Aid/CPR
  • Patient safety monitoring
  • Clinical trial milestone tracking
  • Process improvement
  • Specimen collections
  • Clinical trial risk report generation and distribution
  • Team management

Work Experiences

  • Achieved 68% error-free documentation.
  • Achieved a 48% compliance rate during inspections.
  • Collaborated with investigators to maintain participant safety reporting, ensuring immediate follow-up on serious adverse events per regulatory guidelines.
  • Assisted in managing clinical study documentation.
  • Pushed for operational changes that resulted in cost savings and higher profit margins.
  • Conducted training for site coordinators.
  • Assisted in the development of patient recruitment strategies.
  • Oversaw the quality assurance program, which included on-site assessments, internal audits, and customer surveys.
  • Compiled study protocols and case report forms.
  • Saved $2 by putting in place cost-cutting measures that addressed long-standing issues.

Summaries

  • Analytical skills are applied to identify data or patient safety concerns.
  • Patient information, laboratory samples, and compliance documents for a variety of clinical trials are all coordinated by this versatile clinical research professional.
  • Ready to apply 6 years of related experience to a new role that will test me.
  • Collaborated with data management teams.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the category business.
  • Clinical Project Assistant with 5 years of successful team leadership and vendor management experience.
  • Achieved 100% accurate data submissions.
  • Accomplished in orchestrating patient recruitment strategies that increased trial enrollment by 19% within 18 months. Adept at ensuring compliance and timely reporting of serious adverse events.

Accomplishments

  • Developed tracking systems for trial recruitment progress, which improved participant enrollment completion rates by 68%.
  • Generated key performance indicator (KPI) reports for ongoing studies, providing analysis that led to a 68% improvement in study timelines.
  • Collaborated with data management teams to track data discrepancies, leading to a 38% reduction in query backlogs.
  • Managed IRB/EC submission timelines for 15 clinical trials, reducing approval wait time by 21% weeks.
  • Documented and resolved category which led to process.
  • Improved investigator oversight through proactive communication, increasing protocol compliance rates by 77%.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Assisted in the management of study documentation in eTMF, reducing missing document rate by 67% across trial lifecycle.
  • Utilized CTMS to organize, track, and manage trial milestones, improving on-time task completion rates by 28%.
  • Implemented new processes for tracking investigator contracts, reducing administrative bottlenecks and ensuring on-time signoffs.

Affiliations

  • American Society for Clinical Laboratory Science (ASCLS) membership involving patient monitoring
  • Participation in clinical research roundtables hosted by Cedar Works
  • Association of Clinical Research Professionals (ACRP)
  • Clinical Project Management Alliance (CPMA)
  • International Association of Administrative Professionals
  • Drug Information Association (DIA)
  • Collaborator with Local Clinical Research Groups in Portland
  • Part of Clinical Operations Committee at initiative
  • Good Clinical Practice (GCP) Certification 2018
  • Published research in framework related to clinical trial coordination

Certifications

  • Collaborative Institutional Training Initiative (CITI) Program Certification 2019
  • EudraVigilance Certification Portland
  • Clinical Trials Management Systems (CTMS) Certification HubSpot
  • Data Management in Clinical Research Certification framework
  • Certified Clinical Project Manager (CCPM) - Northwind
  • Clinical Research Associate (CRA) Certification - Vantage
  • Certified Documentation Improvement Specialist (CDIS) – Clinical Research Focus Cedar Works
  • Project Management Professional (PMP) – 2024
  • FDA Good Laboratory Practice (GLP) Compliance Certification 2024
  • Microsoft Certified Systems Engineer (MCSE)

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