Davelle Madden

Research Nursing Project Coordinator at Illingworth Research Group (a Syneos Health Company)
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Contact Information
us****@****om
(386) 825-5501
Location
Raleigh-Durham-Chapel Hill Area

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Experience

    • United Kingdom
    • Pharmaceutical Manufacturing
    • 200 - 300 Employee
    • Research Nursing Project Coordinator
      • Nov 2021 - Present

    • Hospitals and Health Care
    • 100 - 200 Employee
    • Clinical Research Trainee
      • Jul 2021 - Sep 2021

      • ICH GCP E6 R2 • FDA Regulations 21CFR Parts 11, 50, 54, 56 • Data Management Systems, Electronic Data Capture (EDC) systems like Medidata, InForm, MedRio • Informed Consent Process • Clinical Trial Operations from feasibility through close-out (Site and Sponsor/CRO responsibilities and duties • GDP following ALCOA-C principles • Identification and reporting of AEs and SAEs • Quality Assurance, Monitoring and Query Resolution • Comprehension and Execution of Clinical Trial Protocols • Maintaining regulatory binder, housing essential documents including but not limited to 1572, Source documents, DOA, Training Logs, ICF, SAE Forms, Financial Disclosures, Subject Enrollment & Identification Logs, Case Report Forms (CRF), Procedure manuals, Standard Operating Procedures (SOP), Site Visit Logs, Correspondences, Trial Master Files (TMF) and other investigator Site File (ISF) documents Show less

    • United States
    • Education Administration Programs
    • 700 & Above Employee
    • Elementary Educator
      • Apr 2017 - Apr 2021

    • United States
    • Government Administration
    • 400 - 500 Employee
    • Social Clinical Research Associate
      • Mar 2016 - Apr 2017

      • Mined, collected and organized employment and wage data and address information; • Summarized collected data and entered data into the Survey Processing and Management System; • Managed invoices, completed code sheets for purchases and tracked accounts payable payments; • Assisted with purchasing products and services using NC E-Procurement System. • Mined, collected and organized employment and wage data and address information; • Summarized collected data and entered data into the Survey Processing and Management System; • Managed invoices, completed code sheets for purchases and tracked accounts payable payments; • Assisted with purchasing products and services using NC E-Procurement System.

Education

  • Concordia University-Portland
    Master of Education - MEd, Educational Leadership
    2014 - 2016
  • North Carolina Wesleyan College
    Master of Science - MS, Computer Information Systems
    2000 - 2004

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