CRA Onboarding Training Course:
Developed for organizations to train and certify internal Monitors/CRAs, the Institute's CRA Onboarding Training Course is an ideal program to get your new Monitors/CRAs to immediately hit the ground running.
Our intensive self-paced interactive-online training program is designed to ensure that your new hires will be positioned to make an immediate impact, saving your organization time and money. It will rapidly develop competent entry-level Clinical Research Associates (CRAs)/Monitors for clinical trial sponsors and contract research organizations.
The course ensures entry-level CRAs have a demonstrated ability to immediately and successfully manage tasks related to human subject protection, essential document management, monitoring visits and monitoring visit reports, test article accountability verification, and more.
A Clinical Research Associate (CRA) is a profession defined by Good Clinical Practice guidelines (ICH GCP). While ICH GCP uses the term "Monitor" instead of CRA, the two terms are considered to be synonymous.
The main function of a CRA is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a Contract Research Organization (CRO). A Clinical Research Associate (CRA) ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRFs) and communicates with clinical research investigators.
Essential duties of the CRA include:
- Verify that the research site personnel, including the investigators, are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements;
- Ensure reporting of adverse events from research site staff to the sponsor and the IRB/IEC;
- Verify that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source documents (source data verification);
- Review accuracy and completeness of site records (site study file, query resolution, and other data collection tools);
- Verify Investigational Product accountability;
- Complete reporting and ensure management and resolution of all these activities (e.g., visit reports, trial management tracking system);
- Conduct routine monitoring visits on behalf of the clinical trial sponsor.
Training Duration - 30 Hours
• 100% Online, Self-Paced Training, Start Anytime from Anywhere.