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Skills

  • Team building
  • Project organization
  • Resource Allocation Optimization
  • Communications
  • Customer service
  • Budgets
  • Medical writing and communication
  • Informed consent
  • First Aid/CPR
  • Data entry systems improvement

Work Experiences

  • Had an excellent attendance record and was always on time for work.
  • Achieved results within the first two years of direct management.
  • Was in charge of collecting, processing, and shipping lab specimens.
  • Collaborated with system customers to determine their needs and deliver method service.
  • Oversaw the quality assurance program, which included on-site assessments, internal audits, and customer surveys.
  • Analyzed and reported adverse events in a timely manner, maintaining compliance with FDA and international reporting protocols.
  • Analyzed adverse events.
  • Solved program issues, improved operations, and provided excellent customer service.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Placed a high value on punctuality and worked hard to maintain an excellent attendance record, consistently arriving at work ready to work right away.

Summaries

  • Adept at managing complex clinical research budgets.
  • Achieved smooth execution of studies across Portland.
  • During clinical research trials, adept at collecting specimens, dispensing medications, and consulting with patients.
  • Clinical Research Manager focused on trial transparency and data quality management, cutting regulatory delays by 24% and increasing patient retention by 85% across Portland sites.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Strengths in quality assurance and stakeholder engagement backed up by Miscellaneous training.
  • Achieved 85% reductions in trial site activation times.
  • Budget management is certified.
  • Costs were consistently reduced while profits were increased.
  • Within Miscellaneous, senior Clinical Research Manager and outstanding performer in performance reporting and quality assurance.

Accomplishments

  • Provided expert guidance that ensured the clinical data mapping conforming to CDISC standards, leading to 78% reduction in validation timelines.
  • Coordinated and led investigator meetings for over 14 active sites across program, enhancing global trial coordination and compliance.
  • Negotiated key site contracts for Miscellaneous, reducing trial start-up costs by $12, maintaining full adherence to legal guidelines.
  • Played a key role in the submission and approval of Salesforce under fast-track designation, resulting in a 18 months-long reduction in approval timelines.
  • Initiated trial closure procedures for Adobe Creative Suite, achieving full study audits on time and diverting $13 to follow-up activities.
  • Trained clinical site staff on Good Clinical Practice (GCP) guidelines, resulting in a 53% reduction in critical audit findings during three years.
  • Developed tailored training programs that increased the competency of clinical research teams, resulting in a 31% improvement in protocol adherence.
  • Reduced query resolution time by 7 hours in standard system, improving overall trial data accuracy and integrity.
  • Implemented a risk-based monitoring strategy that detected high-risk trial sites early, reducing potential protocol deviations by 84%.
  • Oversaw independent monitoring processes tailored for method trials, resulting in zero critical findings during 14 audits in 2023.

Affiliations

  • Public Responsibility in Medicine and Research (PRIM&R)
  • Association of Information Technology Professionals
  • International Society for Pharma Therapy Research (ISPhR)
  • Phoenix Professional Association for Clinical Research (PACR)
  • Society for Clinical Data Management (SCDM)
  • Lions Club
  • American Society of Safety Professionals
  • Association for the Accreditation of Human Research Protection Programs (AAHRPP)
  • American College of Clinical Trials Management (ACCTM)
  • Association of Clinical Research Professionals (ACRP)

Certifications

  • Apple Certified Associate (ACA)
  • Drug Development and Clinical Research Training – system
  • Microsoft Certified Systems Engineer (MCSE)
  • Human Subjects Protection Training – Northwind
  • Certified Business Analysis Professional (CBAP)
  • Data Management for Clinical Trials Certification – system
  • Project Management Professional (PMP) - Vantage
  • Certified Professional in Clinical Research (CPCR) – Lakeside Partners
  • Advanced Clinical Trial Monitoring Techniques Certification – Ironclad Systems
  • Certified Clinical Research Professional (CCRP) – Summit Group

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