Aug 21, KEMRI Regulatory Coordinator Jobs in Suba/Rongo – Kenya

aug-21,-kemri-regulatory-coordinator-jobs-in-suba/rongo-–-kenya

KEMRI Regulatory Coordinator Jobs in Suba/Rongo – Kenya

Key Responsibilities:

  • 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 Coordinator 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 Coordinator/PI

  • In the absence of the Regulatory Coordinator, one of the regulatory officers assumes the responsibilities of the coordinator in consultation with the study Coordinator/PI.

    Vacancy Requirements:

  • 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

  • Mandatory 2 years of busy Proven clinical research experience working on ethical/regulatory submissions to applicable IRBs.

  • Valid practicing license where applicable

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

    Skills & Competencies

  • Excellent record keeping and filing skills Skills & Competencies

  • 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

    For more information and job application details, see; KEMRI Regulatory Coordinator Jobs in Suba/Rongo – Kenya

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