Elly Walugembe, CRA

Clinical Research Associate II at ACE Research
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Contact Information
us****@****om
(386) 825-5501
Location
Entebbe, Central Region, Uganda, UG

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Credentials

  • Clinical Site Monitoring (CSM) System Training
    National Institute of Allergy and Infectious Diseases (NIAID)
    Jul, 2021
    - Nov, 2024
  • Essential Documents
    National Institute of Allergy and Infectious Diseases (NIAID)
    Jul, 2021
    - Nov, 2024
  • Inspection Awareness and Preparedness for CRS Inspections
    National Institute of Allergy and Infectious Diseases (NIAID)
    Jul, 2021
    - Nov, 2024
  • Preparation for Regulatory Inspections at Laboratories
    National Institute of Allergy and Infectious Diseases (NIAID)
    Jul, 2021
    - Nov, 2024
  • Research Ethics & Informed Consent in Clinical Research
    National Institute of Allergy and Infectious Diseases (NIAID)
    Jul, 2021
    - Nov, 2024
  • Good Clinical Practice Course (US FDA focus)
    IAVI
    Jun, 2020
    - Nov, 2024
  • Human Subjects Protection (HSP)
    CITI Program
    Jul, 2021
    - Nov, 2024

Experience

  • ACE Research
    • Kenya
    • Biotechnology Research
    • 1 - 100 Employee
    • Clinical Research Associate II
      • Nov 2022 - Present

      Perform on-site monitoring visits from pre-study to close-out; Ensure timely, effective communication with investigational sites, within project teams, with the company and as appropriate, with Client; Prepare project-specific support materials and templates in accordance with protocol and other specifications; Manage assigned investigational sites from pre-study to close-out and archiving, including remote or centralized monitoring activities as required; Manage the content of project site-level Trial Master Files and ensure accuracy and completeness; Provide regular progress updates to the Project Lead; Any other reasonable task as approved by your Line Manager; Conduct technical and protocol training of investigational site personnel, as required; Perform site identification, site feasibility and site selection as required; Assist in the preparation and management of regulatory and ethics applications for clinical research studies as required. Show less

  • IAVI
    • United States
    • Research Services
    • 200 - 300 Employee
    • In-House Clinical Research Associate
      • Jun 2021 - Jan 2023

      I was Majorly overseeing and managing quality assurance and control activities in the clinic to follow the ethical standards without compromising the quality of the trial results. I aid quality assurance systems to take care of this critical area in clinical research by focusing on GCP(Good Clinical Practice) and HSP guidelines as per global standards. I was further do the following • Responsible for performing on-site visits (including SIV, IMV, COV). management activities for assigned investigative sites • Assisting site and data management with data query resolution • Collaborated with sponsor CRAs, Clinical Trial Assistant, and Clinical Trial Manager to resolve site issues • Responsible for providing timely and accurate visit reports • Collaborated with CTM to vet vendors for remote electronic consenting initiation • Performed data review for interim and final database locks • Contributed to the finalization of SOPs • Engaged in the launch of the eTMF and CTMS system • Assisted with UAT training • Reviewed site visit reports, follow-up letters, and open action items generated by other quality assurance officers or CTM Show less

  • London School of Hygiene and Tropical Medicine, U. of London
    • United Kingdom
    • Higher Education
    • 700 & Above Employee
    • Clinical Research Coordinator
      • May 2018 - May 2021

      Over seeing day to day activities in the different research hubs, • FDA regulations including 21CFR Parts 11, 50, 54, 56, and the Common Rule • ICH GCP E6 (R2) Guidelines and Protecting the Rights of the patients • Maintaining regulatory binder, housing essential documents including but not limited to 1572, DOA, Training Logs, and other investigator Site File (ISF) documents • Protocol Dissection and Clinical Trial Budgeting • Good Documentation Practices following ALCOA-C principles • Data Management Systems • Adverse Events and Protocol Deviations (Identification and reporting) • Recruitment and Retention of Research Participants • Monitoring, Quality Assurance, and Inspections • Investigator Responsibilities • Clinical Trial Operations from feasibility through close-out • Informed Consent Process Show less

  • Rakai Health Sciences Program (RHSP)
    • Uganda
    • Research
    • 100 - 200 Employee
    • Clinical Trial Assistant
      • Sep 2014 - Apr 2018

      Medical Research – Manage Phase I – Phase IV clinical trials from start-up to trial completion. – Obtain informed consent, reviews medical records, confirm I/E criteria met, take vitals, complete visit procedures – Prepares and manages regulatory documents for IRB approval (ICFs, protocols, advertisement) – Manages data capture, conducts audits regularly, performs data cleaning, ensures quality and data integrity in TMF is GCP compliant – Provides management and leadership to Clinical Operations staff to provide excellent study execution – Supports Clinical Operations in the development, review, maintenance, quality control, distribution, and archiving of clinical study documents and reports. Medical Research – Manage Phase I – Phase IV clinical trials from start-up to trial completion. – Therapeutic Areas: Medical Devices, Endocrine diseases, Nephrology, Cardiology, Vaccine Trials, Neurology, and Biotechnology – Collaborate with internal stakeholders and Principal Investigators to manage recruitment, enrollment, and trial maintenance. – Obtains informed consent, reviews medical records, confirms I/E criteria met, takes vitals, completes visit procedures – Prepares and manages regulatory documents for IRB approval (ICFs, protocols, advertisement) – Manages data capture, conducts audits regularly, performs data cleaning, ensures quality and data integrity in TMF is GCP compliant – Provides management and leadership to Clinical Operations staff to provide excellent study execution – Supports Clinical Operations in the development, review, maintenance, quality control, distribution, and archiving of clinical study documents and reports. Skills: Cardiology • Clinical Research • Clinical Trials • Pharmaceutical Industry • Electronic Data Capture (EDC) • Medical Devices Show less

Education

  • Uganda Martyrs University
    Bachelor of Science - BS, International Public Health/International Health
    2019 - 2022
  • Kabale Institute of Health Sciences
    Diploma in Clinical Medicine and Community Health
    2011 - 2014

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