By Susan Leister, MBA, PhD, CQA, SSBB
Director, Quality Assurance - Technical Resources International, Inc.
Clinical Research Coordinators (CRC) are vital members of the clinical research team. They support, facilitate, and coordinate routine clinical trial activities. CRCs need to be familiar with the various federal and international regulations to understand how they impact the overall clinical trial, especially as it relates to the protection of human subjects and data integrity. Providing continuous training to enhance the competency of your clinical research staff will benefit the overall success of your clinical trials. In addition, having a formal training program that outlines the core curriculum with deadlines will help reduce turnover and enhance employee satisfaction.
CRCs can use project management skills to oversee the clinical research site through tracking and monitoring. Implementing a metrics system and having good time management skills are important to successfully monitor a trial. There are many tools CRCs can use to help with resource management, vendor oversight, and even ensuring clear communication pathways. CRCs take on many different tasks and functions throughout each day and the better equipped they are with the proper tools and training the more successful they will be.
Another important role CRCs hold is in helping to identify, mitigate, and avoid clinical research fraud and misconduct. Understanding how to handle misconduct in the clinical setting is an important and challenging function. One more difficult area for CRCs can be in developing a successful recruitment plan. To help improve recruitment success one can use applicable prescreening methods, follow proper procedures for obtaining an informed consent from subjects, and adapt the recruitment strategies to the protocol. CRCs serve a key role on the clinical research team and there are many tools available to help them perform their multiple duties with confidence. CRC Advanced is a detailed course covering many essential topics such as: project management, fraud and misconduct, subject recruitment and retention, regulatory requirements, and mentoring, statistics and data management.