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Skills

  • Pharmacy operations management
  • Occupancy strategies
  • Inventory and restocking
  • Budget and resource allocation optimization
  • Digital tools for clinical trial coordination (Microsoft Excel)
  • Medication dispensing
  • Training and mentoring
  • Clinical supply chain management
  • Drug utilization review
  • Knowledge of program regulations

Work Experiences

  • Achieved a 36% reduction in query resolution time.
  • Conducted site closure visits.
  • Assisted in managing clinical supply needs.
  • Acted as the primary point of contact for patient queries.
  • Assisted in expanding a clinical study network.
  • Achieved success during 2017's audit cycle.
  • Assisted in the expansion of a clinical study network from 14 sites to 2, improving access to diverse patient populations.
  • Assisted in the management of clinical supply needs, reducing ordering costs by $17 per quarter through optimized forecasting and vendor negotiations.
  • Coordinated cross-functional teams in multi-phase trials for Salesforce, ensuring timely delivery of objectives and adherence to regulatory frameworks.
  • Coordinated clinical study closeout activities and site closure visits, achieving 47% compliance with regulatory framework deadlines.

Summaries

  • Clinical Operations Associate is a multi-talented Clinical Operations Associate who is consistently rewarded for planning and operational improvements.
  • Accelerated approvals.
  • Achieved accelerated approvals within 6 months.
  • Healthcare administrator with a track record of providing high-quality healthcare services to patients.
  • Costs were consistently reduced while profits were increased.
  • Achieved a 72% reduction in trial initiation timelines.
  • Exceptional communicator and proven problem solver.
  • 9 years of experience in multi-site trial management.
  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.
  • Hope to help Northwind achieve even greater success by leveraging my personal skill set and proactive demeanor.

Accomplishments

  • Implemented a new site communication protocol that streamlined investigator queries and reduced turnaround response times by 72%.
  • Directed training sessions for clinical trial coordinators, achieving a 35% reduction in protocol deviations through improved adherence to GCP guidelines.
  • Supported clinical data verification by working closely with the data management team, reducing data discrepancies by 46% across all databases.
  • Developed a site risk assessment strategy, performing pre-monitoring visits that reduced critical findings by 3 during subsequent audits.
  • Supported budgeting and cost projections for 10 clinical trials, maintaining a variance of less than 56% for 2019, ensuring fiscal responsibility.
  • Facilitated the onboarding of 15 new investigators, ensuring all were well-versed in GCP and protocol requirements, leading to faster site activation.
  • Orchestrated the successful close-out of 14 global clinical trials, ensuring all regulatory documents were completed within several months.
  • Served as the key point of contact for study sponsors for 9 projects, ensuring regular updates and timely resolution of escalated site issues.
  • Presented study timelines and updates to stakeholders, delivering all milestones on or ahead of schedule for 23% of enrolled sites.
  • Developed and implemented patient retention strategies across 3 studies, leading to a 54% reduction in drop-out rates.

Affiliations

  • Membership in the Academy of Clinical Research Professionals (ACRP)
  • Deputy Member of the International Conference on Harmonisation (ICH)
  • Rotary International
  • Affiliate member of the Global Health Council (GHC)
  • Contributor to the International Association of Clinical Research Nurses (IACRN)
  • Member of the Clinical Research Society (CRS)
  • Project Management Institute
  • Member of the Association for Clinical Data Management (ACDM)
  • Participant in the Clinical Summary Reports Committee (CSRC)
  • Affiliate of the Society for Clinical Data Management (SCDM)

Certifications

  • Certified Public Accountant (CPA)
  • ServSafe
  • Certified Healthcare Technology Specialist (CHTS), Ironclad Systems
  • Advanced Good Clinical Practice (AGCP) – Lakeside Partners
  • Cisco Certified Internetwork Expert (CCIE)
  • Certified Clinical Operations Manager (CCOM) – Harbor & Co.
  • ISO 14155: Good Clinical Practice for Medical Devices Certification – Summit Group
  • Good Clinical Practice (GCP) - Cedar Works
  • Certified Pharmacovigilance Associate – Northwind
  • SHRM Certified Professional (SHRM-CP)

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