Job Information
Cochlear Americas Clinical Research Associate I in Lone Tree, Colorado
Change people's lives and love what you do! Cochlear is the most recognized brand in hearing health care.
Clinical Research Associate I
- Deadline to apply: November 1, 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 I in our Cochlear America's head office based in Lone Tree, Colorado. This role is hybrid, requiring you to be in the office 2 days per week minimum, with 3 days per week working from home.
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 assigned clinical trials, ensuring compliance with Good Clinical Practice (GCP), Good Documentation Practices (GDP) and all applicable regulatory requirements. You may have some clinical research experience, with cochlear implants or other medical devices, and are familiar with submission of Institutional Review Board (IRB) and Food & Drug Administration (FDA) Investigational Device Exemption (IDE) applications. You demonstrate excellent organization and customer service skills and are comfortable communicating with key stakeholders internally and externally. You have outstanding attention to detail and are accustomed to following through on assigned tasks. Through your effective communication skills you will also be able to influence and support others to complete their tasks according to an assigned project plan. You enjoy problem-sol ving, working with data and demonstrate accuracy and pride in your work.
Key Responsibilities
Accountability 1
Site Management: Support site training, ensuring study site staff 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. Accountability 2
Regulatory Compliance: Ensure all trial activities comply with internal operating procedures, GDP, GCP, and applicable national and international regulations, standards and guidelines. Accountability 3
Clinical Trial Monitoring: Support and prepare documentation for clinical monitoring site visits to ensure compliance with study protocols, regulatory requirements, and GCP guidelines. Develop knowledge and experience of clinical trial execution, GCP and local regulations by addressing site study questions and compliance issues. Accountability 4
Study Documentation & Materials: 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. Accountability 5
Clinical Operations: Support operational aspects of clinical trial including ethics submissions, study device ordering, clinical trial systems (eTMF/CTMS), vendor management, and site compensation. Accountability 6
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.
- 1 - 2 years of experience in medical device industry, with at least 1 year of clinical research experience.
- Awareness of FDA regulations, including Good Clinical Practice (GCP) guidelines, Investigational Device Exemption (IDE) requirements, and Institutional Review Board (IRB) processes.
- Experience with clinical research process, including knowledge of all functional areas of clinical trials and medical terminology.
- Able to travel up to 30% of the time
Total Rewards
In addition to the opport nity to develop your knowledge and grow professionally, we offer competitive wages and benefits.
- The Target Salary Range in the United States: $77,000 - $81,000 per year base salary, based upon experience, as well as an annual bonus opportunity of 7.5% of base salary. Exact compensation may vary 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.