Ashlyn (.

Experience

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  NC Department of Health and Human Services

  May 2018 - Aug 2018

  Epidemiology Intern

  • Served as a member of the Oral Health Epidemiology team. • Gathered data for regional health indicators, evaluated the success of state oral health campaigns and conducted secondary research using the CDC BRFSS database. • Produced, shot, and edited a short documentary celebrating “100 Years of Oral Public Health in NC” that was shown at the 2018 NC Public Health Association Conference.

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  PPD

  May 2019 - Aug 2019

  Clinical Project Management Intern

  • Leveraged Excel to optimize site contact information processes for an idiopathic pulmonary fibrosis study with over 400 sites within the Respiratory & Infectious Disease Department.• Integrated contact information process for new documentation into Clinical Trial Management System (CTMS).• Earned CTMS and Content Server software training.

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  FHI Clinical Inc.

  May 2020 - May 2021

  • Quality Control of electronic Trial Master File (eTMF) system.• Assist in the preparation of study documentation, forms and the development of administrative and filing systems and processes• Assist in the distribution of study documents to investigators and site staff• Maintain up to date participating center’s information (including contact details, contracts, and reports)• Assist in managing effective communication with the study team• Assist project team with other study related activities such as organizing study meetings, producing agendas and minutes for study-related meetings, assemble training and study materials, updating contact details, maintaining study documentation, assisting in the preparation of administrative documents and other tasks as required. Show less

  • Clinical Trial Assistant

    Sept 2020 - May 2021

  • Clinical Operations Intern

    May 2020 - Sept 2020
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  Labcorp Drug Development

  May 2021 - May 2023

  Project, CTMS, project governance tool, and other trackers. Escalate when timelines are at risk. COST: Work with Project Lead to assist with TAQ/TAR (timesheet vs budget) reviews; vendor financial tracking and reconciliation; sponsor contract financial tracking and reconciliation; and final project financial reconciliation. SCOPE: Work with Project Lead to conduct Contract vs. Study Plan Review. Maintain tracker of out of scope (OOS) work performed. Assist the Project Lead to create Change Order Forms. Provide vendor management, escalating OOO activities to Project Lead RISK: Update Xcellerate Risk Identification & Issue Resolution (RIIM) tool; and follow outstanding action items to resolution. Ensure Xcellerate Risk Assessment Categorization Tool (RACT) is complete, using Xcellerate Risk library. Work with Study Team to ensure Protocol Deviations are updated in Xcellerate RIIM QUALITY: Update Project Governance Tool monthly. Support the study team to identify, prevent and close quality compliance gaps. Support the Project Lead to prepare for audits and./or investigations, including creation of story boards to document issues that may occur during the study. Support study team to ensure timely closure of audit/inspection CAPAs TEAM COMMUNICATION: Facilitate study team communication & collaboration by attending & setting up team meetings; updating the ADI log; updating the Task Order Matrix; maintaining the Project Directory; setting up distribution lists, SP sites, mailboxes, and other collaboration tools; and set up / maintain project-specific trackers. TEAM COLLABORATION: Collaborate with other support functions to facilitate timely TMF uploading, TMF reviews, TMF issue resolution, systems access, project-specific training curriculum, and other delegated tasks. Monitor for, escalate, and help to enforce redaction of subject sensitive information and identifiers in any study documentation. Show less

  • Project Coordinator II

    May 2022 - May 2023

  • Project Coordinator I

    May 2021 - May 2022
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  Fortrea

  May 2023 - now

  Project Coordinator II, Global Project Delivery

  Formerly LabCorp Drug Development.The Project Coordinator is the right-hand support to the Project Lead. Work with project team to set up and maintain project schedule. Update timelines within MS Project, CTMS, project governance tool, and other trackers. Escalate when timelines are at risk. Work with Project Lead to assist with TAQ/TAR (timesheet vs budget) reviews; vendor financial tracking & reconciliation; sponsor contract financial tracking & reconciliation; and final project financial reconciliation. Work with Project Lead to conduct Contract vs Study Plan Review. Maintain tracker of out of scope (OOS) work performed. Assist the Project Lead to create Change Order Forms. If no vendor manager assigned, provide vendor management, escalating OOS activities to Project Lead. Update Xcellerate Risk Identification & Issue Resolution (RIIM) tool; and follow outstanding action items to resolution. Ensure Xcellerate Risk Assessment Categorization Tool (RACT) is complete, using Xcellerate Risk library. Work with Study Team to ensure Protocol Deviations are updated in Xcellerate RIIM. Update Project Governance Tool on a monthly basis. Support the study team to identify, prevent and close quality compliance gaps. Support the Project Lead to prepare for audits and/or investigations, including creation of story boards to documenting issues that may occur during the study. Support study team to ensure timely closure of audit/inspection CAPAs. Show less