Clinical Research Coordinator (CRC) Basic Training Online

This course is a five session, intensive online training program designed to meet the needs of coordinators who have less than one year of experience or who have never received formal training. It is useful to anyone who requires a fast, thorough introduction to clinical research trial conduct, Good Clinical Practice (GCP), and the federal regulations governing research. The class is geared toward providing practical information to get students "up and running" in the clinic, with many tools and templates to assist with study implementation.

Course Topics: Informed Consent; Clinical Trial Initiation and Budget Negotiation; FDA Forms and Procedures; Regulatory Documents and Binder Maintenance; Source Documents; Study Initiation and Close-Out Visits; Subject Recruitment, Compliance and Retention; Drug Compliance, Storage, and Documentation; IRBs, IRB Submissions, and HIPAA; Adverse Events and Safety Monitoring; Quality Assurance Audits and Monitor Visits; Preparing for FDA Audits

Class Schedule and Time: The first 30 minutes of the first class session will be dedicated to testing connections and audio. The class facilitator will also be available to answer questions about web-conference functionality and online learning. 

Quarter

Dates

Course Time (CST)

Day of the Week

Registration Deadline

Summer 2015

August 13

August 20, 27, September 3, and 10

9:30am-12:30pm

10:00am - 12:30pm

Thursday

August 7, 2015

Fall 2015

October 1

October 8, 15, 22, and 29

12:30pm-3:30pm

1:00pm - 3:30pm

Thursday September 25, 2015
Winter 2016

January 7

January 14, 21, 28, and February 4

9:30am-12:30pm

10:00am - 12:30pm

Thursday January 1, 2016

PreWork Reading and Assignments: This course includes approximately 20 hours of pre-session reading and assignments that must be completed prior to your first day of class. The pre-session reading and questions are essential to the design of the course as not all basic definitions and principles will be reviewed in detail during the five sessions. We highly encourage the purchase of the course book (The CRC's Guide to Coordinating Clinical Research by Karen E. Woodin, PhD (author) and Sara Gambrill (editor)) which will allow you to complete the reading and assignments as designed. You may also complete the pre-session assignment by utilizing external resources if you wish. The pre-session assignments (pre-work packet) can be downloaded from NUCATS Online after you have registered for the course.

CE Credit and Certificate: This continuing nursing education activity was approved by the Northwestern University Clinical and Translational Sciences Institute. Provider approved by the California Board of Registered Nursing, Provider Number CPN 15198, for 11 continuing education contact hours. Please note that completion of this course will not provide students with certification as a CRC. One to two years of full-time work experience in the field are required before an individual is eligible to sit for the CRA or CRC certification exams.

This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.

Cost and Transfer/Cancellation Policies: The cost of the course is $499 per registration. Cancellations and transfers must be made within 30 days of the registration date and prior to course registration deadline; all cancellations after the course registration deadline will not be refunded. A $75 cancellation fee will be applied to all cancellations. All transfers, including CRC Basic Training Online to CRC Basic Training Live and vice versa, registrant transfers, and course date transfers, will incur a $50 fee. Transfer requests must be submitted by 4pm CST on the Thursday the week before the course starts. Northwestern University reserves the right to cancel any course prior to the course start date and will notify participants accordingly. In such cases, all fees are refunded.

Need more information? Contact one of our RESEARCH NAVIGATORS.