Ellen Looney, who serves as the IRB Coordinator for Pearl IRB, will be the Speaker at a webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on June 19. The topic of this webinar is, “GCP Training for Research Site Personnel”. Description: This webinar provides practical Good Clinical Practices (GCP) training for site personnel and covers the roles and responsibilities of Principal Investigator (PI) and Clinical Research Coordinator (CRC). Anyone involved in the conduct of clinical research should be trained on GCP. GCP is the US standard that provides guidelines for clinical research conduct. Research site personnel are critical for the execution of a successful clinical trial, and these personnel need to be aware of the complexities of GCP. This webinar will cover the important facets of GCP. It is of high value to those who work at a site as a clinical research coordinator and need a deeper dive into GCPs. New PI who would like to learn more than the NIH human subject protection site can provide, and those who are looking for some additional training for their staff will find this session useful. The speaker will offer insights that will be immensely helpful to sponsors who have responsibility for oversight and training of site personnel. The following topics will be covered at this webinar: o Who is responsible for GCP compliance? o FDA GCP regulations o The History of GCP and human subject projection o The International Conference on Harmonization (ICH-GCP) o The roles and responsibilities of the PI o IRB human subject protection regulations ----------------------------------------------------------------------------------------------------------------- When: June 19, 10:00 AM PDT | 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom: Ellen Looney serves as the IRB Coordinator for Pearl IRB. She also provides clinical research consulting assistance for the clients of Pearl Pathways. As a Regulatory Clinical and Quality Associate, Ellen provides GCP guidance, SOP writing, research process support, and research coordinator assistance for client’s studies. Ellen has 15 years of clinical research experience including study design, budgeting and contract negotiation, initiation, study conduct, close-out, and publication. Ellen also has in depth skills in GCP quality systems, SOP creation, data entry and management, and preparation of clinical research documentation for submission to IRB’s. ----------------------------------------------------------------------------------------------------------------- For whom: This webinar will benefit o Research site Principal Investigators o Research site Clinical Research Coordinators o Research Directors at a site, regional hospital or academic center o GCP Auditors o Study Monitors o Sponsor staff who oversee site conduct and provide training to their sites ---------------------------------------------------------------------------------------------------------------- Duration: 60 minutes ----------------------------------------------------------------------------------------------------------------- To enroll for this webinar, contact This email address is being protected from spambots. You need JavaScript enabled to view it. Ph: 800-447-9407 Fax: 302-288-6884

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