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Clinical Research Coordinator Foundations Training Program Overview and Curriculum
The Clinical Research Coordinator (CRC) Foundations Training Program provides a baseline knowledge for students interested in entering the clinical research coordinating profession. Clinical research coordinators are an integral part of the research process engaging in all aspects of clinical trials study management from start-up to close out. By providing students with interactive materials, developed by the Association of Clinical Research Professionals (ACRP) and discussions led by subject matter experts, the program aims to instill foundational skills and abilities required of the entry level clinical research coordinator. In this course, students are introduced to the core competencies according to the International Conference on Harmonization Good Clinical Practice (ICH GCP). Students will learn how to conduct a clinical research trial in compliance with the protocol and ICH GCPs, investigational product maintenance, proper implementation and documentation of informed consent, recruitment, education, and retention of research subjects, provide the IRB/IEC with relevant documents throughout the trial, maintain adequate and accurate source documents, prepare for auditing and monitoring visits, and much more. We will be using a Canvas site as a repository of the class materials and your assignment submissions. All course information and assignments will be organized by week under the tab called Modules.
Course Learning Outcomes and Objectives
- Explain the knowledge, skills, and abilities to be a competent clinical research coordinator
- Describe the different study designs and aspects of protocols
- Describe the general roles and responsibilities of the study personnel
- Describe the required essential documents and documentation best practices for a clinical trial
- Describe the subject recruitment and retention process
- Describe investigational product (IP) management process
- Describe study communication best practices
- Describe the feasibility, site qualification, and site selection process
- Describe a regulatory and ethical informed consent process
- Describe the elements and purpose of good clinical practice (GCPs)
- Describe the monitoring process and the CRC’s role in supporting monitoring
- Define the types of adverse events (AEs) and processes for capturing, assessing, and reporting AEs
Course Requirements
Code of Conduct
This course will be held on the UC Davis Health campus in person on Tuesdays. Shadowing visits will occur on Thursdays for non-UC Davis Health employee students only. On these days and at all times, we expect that you will act professionally and appropriately, as an extension of the UC Davis Health working family. If you feel ill anytime, please do not attend class in person. We will be following current UC Davis Health COVID guidelines. Note that cell phones are not to be used during class time except in emergencies. Lectures and field trips require your full attention and should be treated as if you are at work.
Attire
Please dress appropriately for a professional work environment when on campus. Shorts, distasteful images/slogans on shirts and open-toed shoes will not be accepted. If you are unsure if something should be worn, it probably shouldn’t!
Attendance
Students are expected to attend all in-person activities (i.e., lectures, field trips) on Tuesdays and Thursday (shadowing for non-UC Davis Health employee students). If you know you will be absent, you must notify the instructor ahead of time. Unexcused absences equating to more than 20% (3 days) of in person class time will result in course withdrawal.
Homework Expectations
All homework assignments that are not completed during lectures are to be conducted on your own time. Late assignments will be accepted. More than 3 missing assignments will result in course withdrawal.
Final Entry-Level Knowledge Assessment (ELKA)
While this course is ultimately pass/fail, the final ELKA must be completed with a passing score of 70% in order to receive an official certificate of completion. If students meet or exceed the passing score, a letter of recommendation will be provided signed by the course trainer and program manager for use in future job applications. This course may also be included on resumes and noted as completed training.
Parking
Park in nearby faculty/staff/student lots. Note that we are located at the bottom of the map in the Institute for Regenerative Cures and CTSC Building. The surrounding lots (including the Contractors Lot) should be utilized for parking. Please use the ParkMobile app to pay for parking (register with your UC Davis Health email). Parking will be reimbursed for non-UC Davis Health employee students via a gift card sometime during the course.
Grading
This course has a pass/no pass grading structure. Grading is based on attendance, completion of course assignments/homework, and completion of the ELKA exam.
Example Course Schedule and Due Dates (subject to change)
Course Schedule (PDF)