Davelle Madden
Research Nursing Project Coordinator at Illingworth Research Group (a Syneos Health Company)- Claim this Profile
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Bio
Experience
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Illingworth Research Group (a Syneos Health Company)
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United Kingdom
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Research Nursing Project Coordinator
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Nov 2021 - Present
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Clinical Research Fastrack
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Hospitals and Health Care
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100 - 200 Employee
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Clinical Research Trainee
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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
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Wake County Public School System
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United States
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Education Administration Programs
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700 & Above Employee
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Elementary Educator
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Apr 2017 - Apr 2021
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North Carolina Department of Commerce
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United States
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Government Administration
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400 - 500 Employee
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Social Clinical Research Associate
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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.
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Education
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Concordia University-Portland
Master of Education - MEd, Educational Leadership -
North Carolina Wesleyan College
Master of Science - MS, Computer Information Systems