Ciara Cool

Currently serving as Global Co-lead on a large PMA trial, assisting in the design and authoring of Clinical Investigation Plans (CIP). Lead site qualification, selection, and activation activities in the US and Canada for PMA trials, ensuring regulatory and SOP compliance. Possess significant BIMO inspection experience, leading to two successful trials with PMA approval.

Served as Regional Study Lead for the United States and Canada, overseeing study activities including database snapshots and site initiation visits. Provided direct support to Clinical Research Specialists, delegating tasks and overseeing projects. Authored critical study documents such as Clinical Study Reports and Informed Consent Form Templates.

Managed clinical sites participating in various TAVR studies and led the study team through a Pharmaceuticals and Medical Devices Agency audit with no findings. Co-led the Site Core Team Model project to enhance communication between department study teams. Ensured site compliance with HIPAA, GCP, and IRB policies.

Assisted Clinical Research Specialists and Managers in ensuring document quality, consistent communication, and accurate filing practices. Performed quarterly Trial Master File (TMF) audits for all study sites, reporting findings and assisting in resolving action items. Played a key role in the development of training plans and subject materials.

Led research coordination for pain therapy studies, ensuring compliance with GCP, HIPAA, and IRB policies. Implemented recruitment, screening, and informed consent processes for study subjects. Proficiently utilized Oracle databases and NextGen EHR/EMR software.

Led onsite and online training for new medical scribes across various specialties and coordinated multiple medical scribe programs at Fairview Clinics. Managed all medical scribes in the Emergency Department and Specialty Clinics. Possess extensive experience with the Epic Hyperspace Healthcare system.

Focused on Organizational Ethics and Compliance. This program provided a deep understanding of legal and ethical frameworks relevant to corporate governance and regulatory adherence.

Studied Neuroscience, gaining a comprehensive understanding of the nervous system. The curriculum covered various aspects of brain function, behavior, and neurological disorders.