Job Description

Change people's lives and love what you do! Cochlear is the most recognized brand in hearing health care. Clinical Research Associate II Deadline to apply: October 8, 2024 Change people's lives and love what you do! Cochlear is the most recognized brand in hearing health care. About the role 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. Key Responsibilities Site Management: 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. Regulatory Compliance: Ensure all trial activities comply with interal operating procedres, GDP, GCP, and applicable national and international regulations, standards and guidelines. Clinical Trial Monitoring: Prepare for, and conduct, site visits to ensure compliance with study protocols, regulatory requirements, and GCP guidelines. Study Documentation & Materials: 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. Clinical Operations: Support operational aspects of clinical trial including study device ordering, clinical trial systems (eTMF/CTMS), vendor management, and site compensation. Continuous Improvement: Participate in internal and external audits as needed. Support continuous process improvement efforts. Key Requirements To add value to Cochlear in this role you'll be able to meet and demonstrate the following knowledge, skills and abilities in your application and at interview: 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%. Total Rewards In addition to the opportunity to develop your knowledge and grow professionally, we offer competitive wages and benefits. The Target Salary Range in the United States: $93,000 - $100,000 per year base salary, based upon experience, as well as an annual bonus opportunity of 7.5% of base salary. Exact compensation may va ry based on skills, experience, and location. Benefit package includes medical, dental, vision, life and disability insurance as well as 401(K) matching with immediate vesting, Paid Time Off, tuition reimbursement, maternity and paternity leave, Employee Stock Purchase Plan and pet insurance. Who are we? Human needs have always been our inspira ion, ever since Professor Graeme Clark set out to create the first multi-channel cochlear implant because he saw his father struggle with hearing loss. We always start with people in mind - thinking about their needs. For this reason, our products, services and support will continue to evolve and improve. We are by our customers' side through the entire hearing journey, so they can experience a life full of hearing. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people's lives and working in an organization where they can be part of bringing the mission to life each day. Physical & Mental Demands The physical and mental demands described below are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the individual is regularly required to be in a stationary (seated/standing) position; utilize business technology for work product delivery, communicate orally and in writing with others internal or external to the organization, utilize problem solving/critical thinking skills to discern and convey information. May be asked to occasionally transport/move up to 25 pounds, depending on the position. Specific vision abilities required by this job include ability to adjust focus. The individual is regularly required to utilize comprehension, critical thinking, communication, problem solving, organization reasoning, relating to others and discernment of items such as product specifications, procedures and processes to customers (whether internal or external). Influence, organization/classification of information and planning are also required. The work environment is a home/office, clinical or hospital environment and represents those an individual may encounter while performing the essential functions of this job. Apply now by completing your application form online. Applicants must meet the job specific application criteria to be considered. Visit our careers site at to learn more. Cochlear Americas is an Equal Opportunity, Affirmative Action Employer and provides equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, marital status, veteran status, or any other characteristic protected by federal, state or local law. In addition, Cochlear will provide reasonable accommodations for qualified individuals with disabilities. If you require accommodation with completing the online application, please contact us via web or phone at 303-264-2549.

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