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