Regulatory Coordinator - Suba/Rongo at Kenya Medical Research - KEMRI

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    Mandatory
• Additional training in a management related field and research ethics is an added advantage    Added Advantage
• Mandatory 2 years of busy Proven clinical research experience working on ethical/regulatory submissions to applicable IRBs.    Mandatory
• Valid practicing license where applicable    Mandatory
• 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