Infectious Diseases Institute Regulatory Affairs Assistant Jobs in Uganda

Infectious Diseases Institute Regulatory Affairs Assistant Jobs in Uganda

Key Duties and Responsibilities
  • Working closely with the Monitoring and Regulatory Officer (MRO) on all
    communications, submissions to local and US IRBs and the Sponsors in liaison
    with the study PI’s and Study Coordinators.
  • Assists MRO in planning and conducting training of new and old staff in research
    regulatory compliance and source documentation (New/ongoing studies).
  • Assist the MRO in the development of the QA/QC plan and work closely with the
    PI’s and CQM chief in developing the site QM plans.
  • Quality Control review of the study regulatory files according to Regulatory
    office schedules.
  • Assist the MRO in monitoring the compliance of studies, submitting SAE reports
    to the local IRB and to other local regulatory bodies.
  • In liaison with the MRO, maintain all essential documents across studies
    according to GCP and Sponsor guidelines, IDI policies and advice/ guidance from
    study monitors
  • Assist the MRO and PI during external monitoring/Audit.
  • Follow-up on any regulatory pending issues (submission/approvals).
  • Assist the MRO in reviewing of all participant’s signed informed consents once
    they are delivered to Regulatory office and maintain a confidential tracking log
    for all IC’s across studies.
  • Responsible for tracking of all research regulatory documents e.g. Staff HSP/GCP
    trainings and practicing licenses.
  • Ensure a centralized master files filling system is in accordance with GCP
  • Ensure the functionality of the Regulatory affairs system (RAIS) including
    keeping it updated at all times
  • Assist in ensuring the functionality of Scientific review committee including
    organizing or scheduling its meetings

    Required Qualifications, Skills and Experience
  • Good Clinical Practice (GCP) and Human Subjects Protection (HSP) certificates
  • Bachelor’s degree in a health-related field (preferably Biomedical Sciences)
  • Good knowledge of national and international research ethics guidelines
  • Experience of working in a research setting

    How to Apply;
  • IDI will offer a competitive remuneration package to the successful candidate.
  • Candidates that know that they meet the above criteria and have what it takes to excel
    in the above position, please send their CVs, which should include details of email
    address (if any), present position, current remuneration, Certificate/testimonials and
    address of three (3) Referees plus telephone contact to the stipulated email address not
    later than 30th June, 2019.(Email your application and CV to and let’s
    save the environment).

    Key Notes:

  • IDI is an equal opportunity employer and does not charge a recruitment fee
    or any other fees at any stage of the recruitment process
  • Internal candidates who meet the required specifications and have worked
    with IDI for a period of at least one year will be given priority.
  • Make sure that your application letter, CV and certificates are attached as
    one document
  • Indicate the Vacancy Code as the subject for your email
  • Only shortlisted candidates will be contacted
  • Any form of canvassing will lead to automatic disqualification.
  • The Senior Human Resource Manager
    Infectious Diseases Institute — IDI Knowledge Centre, Makerere University Main
  • College of Health Sciences, Makerere University
  • P.O. Box 22418, Kampala, Uganda
  • For more information and job application details, see; Infectious Diseases Institute Regulatory Affairs Assistant Jobs in Uganda
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