Clinical Research Associate II
: Job Details :

This is a remote Clinical Research Associate II position.Summary: In order to help Cochlear ensure compliance with regulatory requirements, we are recruiting for a Clinical Research Associate II in our Cochlear America's head office based in Lone Tree, Colorado offering a hybrid of remote work environment depending on place of residence with preference for Denver-based candidates. To be successful in this role you will be part of a team that is integral to our clinical research. In this role you will provide support for all operational aspects of clinical trials including set-up, execution and closure, ensuring compliance with Good Clinical Practice (GCP), Good Documentation Practices (GDP) and all applicable regulatory requirements.Responsibilities: Train and support site staff, ensuring they are well-versed in study protocols, procedures and Good Clinical Practice (GCP). Serve as a liaison between the clinical trial sites, project managers, and other stakeholders. Ensure all trial activities comply with interal operating procedres, GDP, GCP, and applicable national and international regulations, standards and guidelines. Prepare for, and conduct, site visits to ensure compliance with study protocols, regulatory requirements, and GCP guidelines. Create, review and maintain essential study documentation. Maintain accurate and timely documentation of all trial-related activities supporting set up, execution and close out of investigations. Support operational aspects of clinical trial including study device ordering, clinical trial systems (eTMF/CTMS), vendor management, and site compensation. Participate in internal and external audits as needed. Support continuous process improvement efforts.Education and Experience: Bachelor's degree in a scientific discipline such as biology, chemistry, or a related field. 2-4 years of experience in medical device clinical research, with at least 2 years clinical monitoring.Certification from recognized bodies such as the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) is preferred. Familiarity with FDA regulations, including Good Clinical Practice (GCP) guidelines, Investigational Device Exemption (IDE) requirements, and Institutional Review Board (IRB) processes.Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology. Proficiency in clinical trial management systems (CTMS) and other relevant software such as eTMF and EDC platforms. Travel requirement is up to 50%.An Equal Opportunity Employer