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Continuing Education Program

Essentials of Initiating Clinical Research

clinical research associate & clinical research coordinator training course

This course is designed to provide a thorough overview of clinical research conduct, the drug development process, the roles of the Clinical Research Associate and Clinical Research Coordinator and other key roles in the conduct of clinical research.


Email: | Phone: 617-552-4256


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NS14601 September 24 to December 3, 2015 Thursdays 6:00pm - 9:00pm $1899 + $125 book fee
NS14602 March 5 to April 9, 2016 Saturdays 9:00am - 3:30pm $1899 + $125 book fee
NS14603 May 17 to June 16, 2016 Tuesdays and Thursdays 6:00pm - 9:00pm $1899 + $125 book fee
Contact hours for this course: 30

Register for Essentials of Initiating Clinical Research,
Project Management in Clinical Research, and
Transitioning into a Career in Clinical Research
together for a $100 discount


In the course of ten classes, experts in the field will guide you to a better understanding of regulatory requirements, ethical issues, Good Clinical Practices, and the many complex responsibilities of these challenging and rewarding positions. This course is meant as an introduction to provide you with a thorough understanding of the basics.  Through actual practice and involvement, you will gain greater knowledge and ability. 

In this course, the research process itself will be dissected, from the inception of generating a research question, to the development of a protocol to test the hypothesis, to the design and interpretation of study results.  Additionally, practical information will be provided regarding today‚Äôs requirements for conducting trials with both drugs and medical devices, with an emphasis on the role of the study personnel in seeing clinical trials to their successful conclusion.

The course includes a strong emphasis on understanding the ethical underpinnings of clinical research and the history of how the field has evolved.  Ethical requirements and the regulatory environment for clinical research have changed over the years, and they still continue to change and progress.

The individual presentations have been selected in order to provide a useful representation of the breadth of clinical research while still allowing enough time and attention to the basics.  This course is meant to continuously evolve, based on changes in the research environment as well as feedback from the students and instructors.  You are encouraged to provide active and meaningful feedback as you progress through this course. 

This course provides a comprehensive overview of clinical development and the responsibilities of Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs). Course content focuses on key concepts and information essential to effectively function in the research arena, introducing new and exciting career opportunities in clinical research. Topics include an overview of drug development and the regulated environment, critical skills and meaningful insights in areas related to the management of pre-study activities, managing the day-to-day activities of a study, tracking the status of all study activities, scheduling study procedures, and developing operational plans. Each module is taught by a professional in the clinical research field.

Module 1: Introduction to Clinical Research, Drug, and Medical Device Development Processes

Module 2: The Clinical Research Landscape: Clinical Research Personnel, Service Providers, and the Site Selection Process  

Module 3: Human Subject Protections and Regulatory Oversight             

Module 4: Institutional Review Boards (IRB), Informed Consent, and HIPAA       

Module 5: Daily Operations: Clinical Trial Conduct, Monitoring, and Record Keeping        

Module 6: Recruitment and Retention, Drug Compliance and Accountability, and Study Close-Out Procedures  

Module 7: Safety Monitoring, Adverse Events, and Unanticipated Problems      

Module 8: Quality Assurance, Audits, and Inspections   

Module 9: Role of Data Management in Clinical Research             

Module 10: Study Budgets and Contracts: Evaluation and Negotiation   


Requests for cancelation and refund are accepted in only in writing (email: at least four weeks prior to the start of the course. A refund is provided (less a $75 administrative fee per course). No refunds will be made for cancellations requested within four weeks of the start date of the course or for no-shows.

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