This course was designed and developed by FCD in collaboration with the Global Health Clinical Consortium (GHCC), Strathmore University, Kenya, and the Institute for Global Health at the University of Siena, Italy. The course is specifically for Study Coordinators, and those working in related roles, who conduct clinical trials in Low-and Middle-Income Countries.
This course is designed for those who currently work in clinical research as a Study Coordinator. It is also suitable for anyone who wishes to work in this field, including investigators, nurses, scientists and clinicians, clinical research associates and clinical monitors, as well as those without formal qualifications.
At the end of this course, successful participants will be able to do the following:
Prepare sites for clinical trial start up through an overall understanding of the clinical trial process from project management to research design and protocol development;
Demonstrate the ability to effectively conduct clinical trials using patient recruitment and retention approaches, data management, data monitoring, pharmacovigilance, safety reporting and good financial practices;
Design and maintain the quality system of a clinical trial through implementing SOPs, handling audits and inspections, as well as other aspects of QA and QC;
Identify and address key challenges in managing research sites including developing and maintaining capacity, doing community engagement and managing grants;
Develop people management skills and techniques that will be useful in working with internal colleagues and external partners
Structure and Duration
This course consists of 10 self-study modules. Each module may require 1-2 hours’ study, depending on your prior knowledge and experience.
For learners who wish to study the topics in depth, a taught version of the course, accredited by the University of Siena is available here.
An electronic certificate of attendance can be obtained once all 10 modules have been studied. Please note: there is no quiz for this course.
The following people made significant contributions to the design, development and delivery of this course:
Sue Ann Costa Clemens
Dawit A Ejigu
Lisa Maria Hodel
Admasu T Mamuye
Gabriela Zepeda Orozco
© FCD 2017
This license allows re-users to distribute, remix, adapt, and build upon the material in any medium or format for non-commercial purposes only, and only so long as attribution is given to the creator. If you remix, adapt, or build upon the material, you must license the modified material under identical terms.
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