The Clinical Research Coordinator Workshop is a two day course designed for any individual who will be assuming the responsibilities of a clinical research

“The training really helped me.   Compared to online training, the one on one training allowed me to ask questions and get answers during the training.  If I did not understand a certain aspect, the trainer was able to take the time and help me understand.” Lubna Hooda Rockville, MD

coordinator (CRC). Depending upon experience, this workshop can be tailored for the novice or the expert.

Using a one-on-one training approach, this workshop pairs a certified clinical research professional with the coordinator(s) at your site, allowing us to customize the workshop to meet your site’s specific needs.

The primary goal of the workshop is to instruct the clinical research coordinator on the proper way to conduct a clinical trial. This is accomplished by focusing on the regulations that govern clinical trials (CFRs, ICH Guidelines, and GCPs) and the role and responsibilities of a CRC. Teaching methods include hands on experience using mock clinical trial examples that will prepare the clinical research coordinator for various tasks and challenges. At the conclusion of the workshop, a test will be given to the participant to highlight areas of strength and opportunities for growth.

Upon completion of the workshop, the attendee should be able to:

• Discuss the general guidelines and regulations that govern clinical trials.
• Describe the various participants of a clinical research trial and understand their roles.  
• Identify regulatory and essential documents and describe their function within a clinical trial.
• Describe the various aspects of the informed consent process and how to properly consent patients. 
• Understand the function and role of an IRB and how to submit documents for review.
• Understand the importance of capturing and reporting key data, such as AEs, SAEs, and protocol deviations.
• Discuss the role of the Study Coordinator including: the regulatory process, setting up local procedures; source documentation management and control; proper CRF completion and the DCF process, working relations with CROs and sponsors; and organizational skills.
• Implement recruitment strategies for upcoming trials.
• Discuss the rationale and issues surrounding the monitoring visit and the audit process both from a site, a sponsor and a regulatory perspective.
• Discuss the philosophy and rationale for the development and implementation of Standard Operating Procedures