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Skills

  • Research SOPs understanding
  • Communications
  • Budgets
  • Mathematical formula application
  • Credit and collections
  • Consumer behaviors
  • Economic growth factors
  • Trip reports
  • Heavy lifting
  • Labor force participation

Work Experiences

  • Followed informed consent procedures and kept track of everything.
  • Identified
  • Exercised and practiced under the supervision of athletic trainers or professional coaches to develop skills, improve physical condition, and prepare for competitions.
  • Completed the work outlined on the repair order with efficiency and accuracy.
  • Organized and maintained research study regulatory documents in a site binder to maintain accuracy and integrity.
  • Solved
  • Was in charge of receiving, storing, transferring, and dispensing petroleum fuel products.
  • Recommendation
  • Made a proposal
  • Invented

Summaries

  • Valuable and hardworking employee with a track record of converting cold calls into profitable sales relationships.
  • Multi-tasking, self-motivated leader with experience expanding network connections, persuading customers to buy products, implementing pricing models, inventory control and projections, territory development, and uncovering customer needs to deliver solutions.
  • Advanced planning, problem-solving, and communication skills honed over 4+ years of successful clinical research.
  • Dependable and courteous self-starter and team player seeking to apply previous experience to a process position with a forward-thinking organization.
  • Demonstrated ability to conduct clinical site visits and resolve issues related to participant eligibility, database protocols, and study procedures.
  • Adaptable, tenacious, and capable project manager with over 12 years of experience leading teams, resolving conflicts, networking with prospects, and managing budgets to maximize profits.
  • Expertise in overseeing product development from concept to completion, including packaging design, marketing, and promotional materials.
  • Ambitious
  • Program and procedure are examples of abilities.
  • Service-driven

Accomplishments

  • Collaborated with cross-functional teams to streamline regulatory submission processes, resulting in 8% faster approval timelines for SAP trials.
  • Led resolution of critical protocol deviations by identifying root causes, which mitigated potential risks and maintained study integrity for Tableau trial.
  • Played a pivotal role in navigating through regulatory constraints, accelerating study initiation timelines by 7 weeks for an oncology trial.
  • Managed clinical trial document management systems to ensure CFR-compliance, streamlining the regulatory audit process and reducing findings in 2018.
  • Successfully oversaw patient recruitment initiatives, resulting in a 46% enrollment increase for trials in rare disease indications.
  • Reduced clinical trial monitoring costs by $3 annually by implementing risk-based monitoring and remote monitoring strategies.
  • Played a key role in executing re-consent strategies during protocol amendments, maintaining 42% patient retention and data integrity throughout the process.
  • Coordinated with global sites to resolve data discrepancies using Microsoft Excel, ensuring a timely database lock for submission in 2021.
  • Facilitated cross-department collaboration to redesign patient-centric approaches that improved trial participation rates for initiative clinical studies.
  • Managed data lock and database freeze processes, which reduced the overall timeline of study close-out by 15 weeks for Jira clinical trials.

Affiliations

  • Global Health Clinical & Research Association
  • Society of Women Engineers
  • International Clinical Trials Network (ICTN)
  • Pharmaceutical Research and Manufacturers of America (PhRMA)
  • Association of Clinical Research Professionals (ACRP)
  • Infectious Diseases Society of America (IDSA)
  • Drug Information Association (DIA)
  • Regulatory Affairs Professionals Society (RAPS)
  • Society for Clinical Data Management (SCDM)
  • International Council of Nurses

Certifications

  • CompTIA A+ Technician
  • CompTIA Security+
  • Microsoft Certified Systems Engineer (MCSE)
  • Clinical Trials Auditing Certification - Harbor & Co.
  • Certified Business Analysis Professional (CBAP)
  • Certified Public Accountant (CPA)
  • Cisco Certified Internetwork Expert (CCIE)
  • Pharmaceutical Budget Management Certification - Vantage
  • ICH E6 (R2) GCP Certification - Summit Group
  • Regulatory Affairs Certification (RAC) - Summit Group

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