Course Overview

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.

Target Audience

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.

Learning Objectives

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.  

Certification

An electronic certificate of attendance can be obtained once all 10 modules have been studied. Please note: there is no quiz for this course.

Course Contents

Module 1

Introduction to Clinical Research Operations

Module 2

Data Management and Biostatistics 

Module 3

Study Design and Protocol Development 

Module 4

Conducting a Clinical Trial (Part 1)

Module 5

Conducting a Clinical Trial (Part 2)

Module 6

Project and Financial Management (Part 1, Project Management) 

Module 7

Project and Financial Management (Part 2, Financial Management) 

Module 8

Working with External Partners

Module 9

Quality Systems, Audits and Inspections 

Module 10

Pharmacovigilance 
 

CERTIFICATE OF ATTENDANCE

Acknowledgements

The following people made significant contributions to the design, development and delivery of this course:

Ghiorghis Belai

Sutinder Bindra

Simon Bolo

Gavin Chait

Sue Ann Costa Clemens

Helen Demarest

Shaantanu Donde

Dawit A Ejigu

Tim Grant

Soumya Hazra

Lisa Maria Hodel

Renee Holt

Sandra Johnson

Jennifer Lehrman

Admasu T Mamuye

Emanuele Montomoli

Pamela Nabeta

Alice Neequaye

Bernhards Ogutu

Brenda Okech

Florence Oloo

Russ Orrico

Victorine Owira

Thy Pham

Swapnali Raut

Kathryn Rutkowski

Bethseba Siddondo

Mercury Shitindo

Mahnaz Vahedi

Jim Whalen

Jeremy Whitty

Sinéad Whitty

Gabriela Zepeda Orozco

Copyright
© FCD 2017

  CC BY-NC-SA

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. 

How to Cite:
Cite this course as Clinical Research Operations for Study Coordinators, by FCD, as hosted on The Global Health Network, licensed under CC BY-NC-SA.

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