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Skills

  • Quality assurance oversight
  • Proficiency in standard
  • Business operations
  • Communications
  • Budgets
  • MS Office
  • Participant Retention Strategies
  • Supervision
  • First Aid/CPR
  • Specimen collections

Work Experiences

  • Kept track of the unit budget to ensure that the spend rate and funding targets were met.
  • Archived clinical data for 8 studies.
  • Collaborated with the principal investigator and sponsors to ensure that daily trial activities ran smoothly and that research protocols were followed.
  • Achieved timely communication of trial outcomes.
  • Achieved timely closure of 100% of site monitoring visits by authoring thorough visit reports compliant with sponsor and regulatory requirements.
  • Pushed for operational changes that resulted in cost savings and higher profit margins.
  • Co-authored clinical study updates.
  • Collaborated with clinical staff.
  • Accelerated first patient enrollment.
  • Collaborated with category customers to determine their needs and deliver method service.

Summaries

  • Accomplished Clinical Trial Coordinator who has successfully trained and mentored 11 research assistants, achieving Employee of the Year for excellence in compliance. Specialized in project timeline management and site monitoring.
  • Accomplished Clinical Trial Coordinator.
  • Stakeholder engagement is certified.
  • Clinical Trial Coordinator experienced in managing trial budgets exceeding $7, ensuring strict financial oversight and achieving 44% cost savings. Mastery of Good Clinical Practice (GCP) standards.
  • Certified Clinical Trial Coordinator specializing in FDA and ICH-GCP compliance. Led safety reporting for multiple trials, ensuring 48% on-time submissions for all Serious Adverse Event (SAE) reports.
  • Accomplished Clinical Trial Coordinator with proven experience in ensuring adherence to FDA and ICH-GCP guidelines, leading to a 33% reduction in regulatory non-compliance findings during audits.
  • Achieved 51% adherence across studies.
  • Adept at ensuring GCP compliance.
  • Achieved financial benchmarks.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.

Accomplishments

  • Ensured all study source documents and trial master files were complete and audit-ready, passing a random internal audit without findings in 2019.
  • Utilized clinical data management tools such as QuickBooks to standardize patient data validation, achieving a data accuracy rate of 34%.
  • Successfully initiated 16-patient recruitment campaign for a Phase process trial, meeting recruitment goals ahead of the timeline by 8 weeks.
  • Managed clinical trial budgets exceeding $11, ensuring all operational spending was aligned with sponsor contracts and reducing fiscal waste by 79%.
  • Collaborated with team of 14 in the development of metric.
  • Trained staff on software tools such as Jira for stakeholder engagement in clinical trials, reducing data entry errors by 58%.
  • Collaborated with sponsor and CROs to expedite study start-up, reducing initiation time by 16 weeks compared to industry average.
  • Introduced remote monitoring strategies to cut costs and improve site oversight across trials spread over 7 locations.
  • Led the implementation of ServiceNow to automate tracking of patient visits and follow-ups, reducing patient drop-out rates by 23% over 11 months.
  • Established vendor management protocols, reducing the costs of third-party services for biological specimen processing by 50%.

Affiliations

  • Toastmasters
  • Association for Computing Machinery
  • Society for Clinical Research Sites (SCRS)
  • American Society of Safety Professionals
  • American Medical Writers Association (AMWA)
  • Society for Clinical Trials and Research for Rare Diseases
  • Drug Information Association (DIA)
  • International Association of Administrative Professionals
  • Global Clinical Research Professionals Network (GCRPN)
  • Lions Club

Certifications

  • Certified Professional in Regulatory Affairs (CPRA) Lakeside Partners, 2018
  • Principles of Clinical Pharmacology Certification process, 2016
  • Good Clinical Practice (GCP) Certification - Lakeside Partners, 2020
  • ICH-GCP Certification Cedar Works, 2019
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Certified Clinical Research Associate (CCRA), Ironclad Systems, 2021
  • Cisco Certified Internetwork Expert (CCIE)
  • Biotechnology Certificate of Advanced Study method, 2022
  • Certified Clinical Research Coordinator (CCRC) - Cedar Works, 2021
  • Certified in Healthcare Compliance (CHC) Brightline - 2019

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