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Skills

  • Operational improvement
  • Clinical study milestone tracking
  • Relationship development
  • Study protocols
  • First Aid/CPR
  • Patient follow-up and retention strategies
  • Clinical trial budget variance analysis
  • Documentation review and approval
  • Supervision
  • Regulatory compliance

Work Experiences

  • Adjusted staffing needs for study duration.
  • Conducted data reconciliation processes.
  • Looked for industry trends on social media and through online sources.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Conducted site monitoring visits.
  • Achieved a 100% patient follow-up rate over 12 months.
  • Acted as primary point of contact for regulatory inspections, successfully maintaining full compliance with initiative standards.
  • Achieved zero shipment delays.
  • Clinical trials for disorders like program and system were coordinated by me.
  • Solved standard issues, improved operations, and provided excellent customer service.

Summaries

  • Adept at managing multiple trials.
  • Data analysis is certified.
  • Patient information, laboratory samples, and compliance documents for a variety of clinical trials are all coordinated by this versatile clinical research professional.
  • Adept at navigating FDA guidelines.
  • Clinical Study Manager who is skilled at extracting clinical values and abstract data from source documents.
  • Costs were consistently reduced while profits were increased.
  • Adhered to study timelines.
  • Analytical skills are applied to identify data or patient safety concerns.
  • Adept at managing multiple trials at once while maintaining stringent oversight, improving protocol adherence by 79% and reducing risks in patient safety.
  • Adept at vendor management.

Accomplishments

  • Orchestrated the operational setup for Phase 14 trials across Austin, ensuring all clinical sites adhered to protocol-specific requirements.
  • Led a cross-functional team in the development and submission of protocol amendments, decreasing regulatory review time by 65%.
  • Developed risk management plans and successfully mitigated trial risks, ensuring trial completion within the projected timeline and budget.
  • Spearheaded the onboarding of 11 clinical trial sites, coordinating site qualification and achieving readiness within 69% of the planned timeline.
  • Monitored study timelines, ensuring database lock was achieved in under several months, facilitating quicker access to analyzed data.
  • Presented key findings to senior leadership and external committees, facilitating informed decision-making regarding trial continuation.
  • Effectively managed adverse event (AE) reporting protocols, ensuring accurate and timely communication to regulatory bodies within three years.
  • Supervised clinical monitoring activities across 3 sites, ensuring consistent delivery of high-quality data across geographically dispersed regions.
  • Developed and maintained positive relationships with clinical investigators, which boosted site satisfaction rates and improved participant retention by 73%
  • Developed and executed data-driven trial strategies which facilitated an early database lock, reducing trial close-out costs by $13.

Affiliations

  • American Society of Safety Professionals
  • North American Association for Statistics in Clinical Trials (NAASCT)
  • Project Management Institute (PMI) - Project Management Professional (PMP)
  • Society of Women Engineers
  • European Union Clinical Trials Association (EUCTA)
  • Association of Clinical Research Professionals (ACRP)
  • Lions Club
  • American Marketing Association
  • Association for Supply Chain Management (APICS)
  • Association of Information Technology Professionals

Certifications

  • Certified Public Accountant (CPA)
  • Cisco Certified Network Associate (CCNA)
  • First Aid/CPR Certified
  • Apple Certified Associate (ACA)
  • SHRM Certified Professional (SHRM-CP)
  • Cisco Certified Internetwork Expert (CCIE)
  • Clinical Trial Project Management Certification
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Patient Recruitment and Retention Strategies for Clinical Trials
  • Health Insurance Portability and Accountability Act (HIPAA) Compliance Certification

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