Clinical Research Operations for Study Coordinators

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