Regulatory Clinical & Quality Associate,
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. These experiences range from Phase I-IV, over-the-counter, device, and nutraceutical studies. Prior to joining Pearl, Ellen served in roles with sponsors, a Phase I research unit, and as a CRC at a research site.
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. She served as a clinical research coordinator and associate, project manager, and clinical document associate, which all required deep knowledge of FDA and ICH guidance and regulations. In addition to these titles, Ellen has held positions leading in-house management and QA of clinical regulatory documents, logging and filing, auditing, and ensuring completeness and accuracy of clinical regulatory files.
Ellen is CCRP certified with a Bachelor’s degree from Indiana Wesleyan University.