KEMRI Regulatory Coordinator Jobs in Kenya

KEMRI Regulatory Coordinator Jobs in Kenya


  • Bachelor’s degree in Health or social sciences from a recognized university.

  • A relevant master’s degree is preferred
    Additional training in a management related field and research ethics is an added advantage

  • Proven experience working on ethical/regulatory submissions to applicable IRBs

    Duties and Responsibilities

  • The Regulatory Coordinator is immediately responsible for all aspect of the ensuring regulatory compliance of the study intervention.

    Specifically, the Regulatory coordinator is responsible for:

  • Leading development and maintenance of Study Master File/Investigator Site Files
    Preparing the sites for external study monitoring visits and writing post visit reports

  • Acts for and on behalf of the study manager with regards to regulatory compliance
    Works together with the study coordinators/HoDs in ensuring timely submissions to KEMRI SERU/PPB

  • Oversee maintenance of Trial Master File and/or Investigator Site File (ISF)

  • Maintaining up to date regulatory binders for the study including the Study Master File (SMF) essential documents, delegation of duties log, training files, etc

  • Planning and conducting internal site monitoring for the study and following up on proposed action plans

  • Working with external monitors during monitoring visits and spearheading resolution of monitoring visit clarification forms

  • Coordinating and documentation of study related internal trainings/curricular

  • Active role in review process for study SOPs

  • Checking and ensuring regulatory compliance by all departments of the study

  • Working with the Clinic team on Protocol deviations/violations and SAE/UAE reporting especially with regards to maintenance of logs and filing of reports

  • Working with respective departments on implementation of the Study Quality Management Plan

  • Other duties as delegated by the Study Manager/PI

  • In the absence of the Regulatory Coordinator, one of the regulatory officers assumes the responsibilities of the coordinator in consultation with the study manager and other HoDs.

    Other Require skills

  • Comfortable with paperwork with a strong bias towards GCP/GCLP reviews

  • Excellent record keeping and filing skills

  • Exceptional reporting and report writing skills in relation to research studies

  • Ability to multitask, problem solve, and work with others to resolve challenges.

  • Strong communication, training/teaching, leadership skills

  • Excellent organizational skills and demonstrated competence with managing administrative records.

  • Excellent interpersonal and communication skills; able to communicate effectively both orally and in writing

  • Ability to monitor, gather and evaluate information of broad scope and complexity

    How to Apply

  • Interested candidates who meet the above criteria are encouraged to send in their applications through email;

    Applications should include the following:

  • A cover letter stating current position and date available to start working for the program

  • A current CV including email and mobile phone contact

  • Name and phone number for two professional referees

  • Two letters of recommendation

  • A copy of the latest pay slip (if applicable)

  • Copies of academic and professional certificates

  • Kemri is an equal opportunity employer commited to diversity; persons with disability, women, youth and those from marginalized areas are encouraged to apply. Kemri does not charge a fee at any stage of its selection process including application, interview and processing of offer letter. If asked for a fee, report such request immediately.

  • Only shortlisted candidates will be contacted.

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