The Clinical Research Coordinator (CRC) has a vital role in the conduct of a clinical trial and is a key liaison between the investigator, subject, IRB, and sponsor. The online 10-Week Clinical Research Coordinator (CRC) On-Boarding Program will provide a comprehensive introduction to clinical research and the job functions of the CRC for both drug/biologic and device trials. This program will provide core skills and encourage critical thinking to those individuals looking to support, facilitate, and coordinate the daily activities of clinical trials. Case studies and industry best practices will be presented to underscore how the learning objectives apply directly to the responsibilities of the CRC.
The resources required to take this on-line course are already at your fingertips - an Internet connection and a phone. After registering, you will receive an email confirmation that provides you with the Web Seminar link and audio connection information.
Prior to the start of the course, participants will receive comprehensive course materials. Come to class prepared to interact – you will be able to ask questions, provide feedback and participate in discussions and group work. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.
- Describe the roles and responsibilities of the Clinical Research Coordinator
- Prepare for what a pharmaceutical or device sponsor is looking for in a research site during a pre-study evaluation or site selection visit
- Describe the requirements for source documentation, case report forms, study tool development, and standard operating procedures (SOPs)
- Define informed consent requirements and learn the process of conducting informed consent
- Define safety definitions and reporting requirements for both drugs and devices
- Discuss regulatory compliance and quality assurance as it relates to audits and inspections
- Module 1: Introduction to Clinical Research, Investigational Product and Device Development, Regulatory Oversight, and Good Clinical Practice Guidelines
- Module 2: The Clinical Research Team: Roles and Responsibilities
- Module 3: The Principal Investigator and Site Selection
- Module 4: Clinical Study Protocol Breakdown and Feasibility Evaluation
- Module 5: Source Documentation, Case-Report Forms, Study Tool Development, and Standard Operating Procedures
- Module 6: Informed Consent Requirements and Process
- Module 7: Study Initiation, Start-up, and Ongoing Management Activities and Sponsor Expectations
- Module 8: Safety Reporting: Definitions and Reporting Requirements
- Module 9: Accountability for the Test Article and the Trial Termination Visit
- Module 10: Regulatory Compliance and Quality Assurance: Audits and Inspection
- Aspiring CRCs (This course is also appropriate for CRCs with less than six months of experience)
- College Students and New Graduates in a Scientific Field
- Nurses interested in developing skills in clinical research
NOTE: This course is for individual registrants only and does not allow for group training.
What previous students have said ...
“The course provided useful tools. It was easy to ask questions and the weekly online course format allowed time for the new material to be absorbed, before adding new content. It was manageable, even with a
full time job.”
“Lessons learned in this seminar are already being put to practice in my day-to-day Oncology Research Coordinator position. This course has given me a clear picture and understanding of the drug development process to the time study closes and the drug is marketed. This is a great wealth of knowledge and the course was very informative. Thank you!“
“I am already using almost everything that we went over in class in my day-to-day activities! Thank you so much for a wonderful class!”
“Clinical research is a new world for me and I am grateful for the opportunity to take what I’ve learned in the course and apply it!”
This course will be taught by one of the following instructors:
Marla Hoelle, R.N., B.S.N., C.C.R.A., P.M.P.
Janet Ellen Holwell, C.C.R.C., C.C.R.A.
Click here for complete trainer biographies
10 weeks for 3 hours each week.
Friday mornings, 8:30 – 11:30 a.m. Eastern. Friday afternoons, 12:00 - 3:00 p.m. Eastern.
$1,695 by Early Bird Deadline noted in Upcoming Courses section above
$1,895 after Early Bird Deadline
This course is for individual registrants only and does not allow for group training.
Certificates of Attendance, and accreditation, provided that accreditation requirements are met.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 30 hours (3.0 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-14-088-L01-P. Released: 8/14.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.