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.
|9/25/14 - 12/04/14
6:00pm - 9:00pm
|3/07/15 - 4/11/15
9:00am - 3:30pm
|5/19/15 - 6/18/15
||Tuesdays & Thursdays
6:00pm - 9:00pm
|Contact hours for this course: 30.0|
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’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.
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 to transfer payments to another course, and cancellations, are only accepted in writing (or by e-mail to firstname.lastname@example.org) four weeks prior to the start of the course.
A refund (less $70 administrative costs) is provided only if a cancellation is requested in writing (or by e-mail to email@example.com) four weeks prior to the start of the course. No refunds will be made for cancellations requested after that date or for no-shows.