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Continuing Education Program

Clinical Research I: Understanding Concepts and Process
Clinical Research II: Implementing Protocols and Procedures

clinical research associate & clinical research coordinator training course

CR Professionals

These two courses consist of ten sessions. 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. These courses are 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. 

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’s 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.

These courses include 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. 

Gain a comprehensive ubderstanding of clinical development and the responsibilities of Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs). Each sessions 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.


 

Clinical Research I: Understanding Concepts and Process

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.

Session 1: Overview of the Clinical Research Process

Session 2: Clinical Research Personnel, Service Providers and the Site Selection Process

Session 3: Human Subject Protections and Regulatory Oversight           

Session 4: Roles and Responsibilities of Clinical Research Coordinators (CRC) and Clinical Research Associates (CRA)     

Session 5: Components of Ethical Evaluation of Human Research and Privacy Considerations        

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


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Clinical Research I is offered three times annually

COURSE DATES DAYS AND TIMES TUITION
AND FEES
NS14101 September 22 - October 27, 2016 Thursdays 6:00pm - 9:00pm $1199 + $75 book fee
NS14102  February 25 - March 11, 2017 Saturdays 9:00am - 3:30pm $1199 + $75 book fee
NS14103-D May 16 – June 1,  2017 Tuesdays and Thursdays 6:00pm - 9:00pm $1199 + $75 book fee
Contact hours for this course: 18

Register for Clinical Research I & II, Project Management in Clinical Research, and Transitioning into a Career in Clinical Research together for a $200 discount


 

Clinical Research II: Implementing Protocols and Procedures

Session 1: Pharmacovigilance in Drug/Device Development Problems

Session 2: Audits & Inspections: Ensuring Clinical Research Quality

Session 3: The Role of Data Management in Clinical Research

Session 4: Study Budgets and Contracts: Evaluation and Negotiation 

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Clinical Research II is offered three times annually

COURSE DATES DAYS AND TIMES TUITION
AND FEES
NS14201 November 3 - December 1, 2016  Thursdays 6:00pm - 9:00pm $859
NS14202 March 18 & 25, 2017 Saturdays 9:00am - 3:30pm $859
NS14203-D June 6 - 15,  2017 Tuesdays and Thursdays 6:00pm - 9:00pm $859
Contact hours for this course: 12

Register for Clinical Research I & II, Project Management in Clinical Research, and Transitioning into a Career in Clinical Research together for a $200 discount

REFUND AND CANCELLATION POLICY

Requests for cancellations and refunds are accepted in only in writing (email: sonce@bc.edu) 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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