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Skills

  • Medication dispensing
  • International regulatory approvals
  • Mentorship and team development
  • Wellness services
  • Patient recruitment strategies
  • Compliance with ICH-GCP guidelines
  • Data collection accuracy improvement
  • Cross-functional team leadership
  • Seasoned in medical clinical procedures
  • Protocol deviation monitoring

Work Experiences

  • Achieved a 83% increase in clinical trial enrollment rates.
  • Collaborated with principal investigators to design and monitor phase 11 trials, reducing protocol deviations by 38%.
  • Collaborated with principal investigators.
  • Hired, trained, and supervised all employees, as well as providing direct supervision, ongoing staff development, and continuing education.
  • Provided information on various immunizations to patients and patrons, including flu, DTaP, and HPV vaccines.
  • Was in charge of ordering all pharmacy supplies and keeping track of inventory levels.
  • Achieved 65% higher retention rates.
  • Cleaned up the pharmacy area by removing trash and straightening the counters.
  • Authored standard operating procedures (SOPs) for clinical activities.
  • Collaborated with data management teams.

Summaries

  • Aligned clinical objectives with corporate goals.
  • Dedicated Pharmacy Manager with experience with regulatory requirements and a passion for assisting people from all walks of life.
  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.
  • Staff development that results in high-performing teams has been recognized.
  • Achieved 53% return on investment.
  • Healthcare administrator with a track record of providing high-quality healthcare services to patients.
  • Professional with experience in recruiting, training, and managing employees to provide exceptional resident services in the healthcare industry.
  • Astute professional with extensive experience in pharmacy operations and performance metrics.
  • Achieved 31% alignment with corporate objectives.
  • Hope to help Lakeside Partners achieve even greater success by leveraging my personal skill set and proactive demeanor.

Accomplishments

  • Presented protocol amendments to regulatory bodies, expediting approval by 9 months and positively impacting trial timelines.
  • Reduced total site activation time by 84% through enhanced project management and proactive site engagement strategies.
  • Collaborated with the data management team to refine data collection processes, increasing data accuracy by 51%.
  • Monitored pharmacovigilance activities in post-market surveillance, achieving a 31% reduction in serious adverse events through proactive risk management.
  • Spearheaded the redesign of clinical monitoring procedures, reducing cycle times by 28% and maintaining compliance across all regions.
  • Optimized trial site management across 10 regions, improving data collection accuracy by 37% and bolstering trial validity.
  • Achieved a President's Club for category by ensuring zero critical findings during regulatory inspections of 17 clinical sites.
  • Successfully maintained adherence to regional, national, and global regulatory frameworks, contributing to receipt of Top Performer for ethical standards in clinical research.
  • Led cross-functional efforts in writing and submitting 7 clinical trial regulatory packages, achieving successful approvals on first submission.
  • Drove forward-thinking strategies aimed at enhancing patient engagement, resulting in a 73% increase in retention rates across 3 clinical studies.

Affiliations

  • Drug Information Association (DIA)
  • American Society for Quality (ASQ) Healthcare Division
  • Association of Information Technology Professionals
  • The Organization for Professionals in Regulatory Affairs (TOPRA)
  • Biotechnology Innovation Organization (BIO) Clinical Development Committee
  • World Medical Association (WMA)
  • Medical Device Innovation Consortium (MDIC)
  • Society of Clinical Research Associates (SOCRA)
  • International Council of Nurses
  • International Association of Administrative Professionals

Certifications

  • ICH Good Clinical Practice (ICH-GCP) Refresher - 2020
  • SHRM Certified Professional (SHRM-CP)
  • Clinical Trial Audits Certification by Cedar Works - 2017
  • Cisco Certified Network Associate (CCNA)
  • ServSafe
  • Project Management Professional (PMP)
  • Certified Clinical Research Professional (CCRP) - 2019
  • Certified Public Accountant (CPA)
  • ISO 9001 Quality Management Systems Certification (Ironclad Systems, 2019)
  • Certified Professional in Clinical Research (CPCR) - 2023

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