Clinical Research Associate I
3 weeks ago
About the Role
Cochlear Americas is seeking a Clinical Research Associate I to join our team in Lone Tree, Colorado. As a Clinical Research Associate I, you will play a critical role in ensuring compliance with regulatory requirements and supporting the execution of clinical trials.
Key Responsibilities
- 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.
- Regulatory Compliance: Ensure all trial activities comply with internal operating procedures, GDP, GCP, and applicable national and international regulations, standards, and guidelines.
- Clinical Trial Monitoring: Support and prepare documentation for clinical monitoring site visits to ensure compliance with study protocols, regulatory requirements, and GCP guidelines.
- 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.
- Clinical Operations: Support operational aspects of clinical trial including ethics submissions, 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.
Requirements
- Bachelor's degree in a scientific discipline such as biology, chemistry, or a related field.
- 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 opportunity to develop your knowledge and grow professionally, we offer competitive wages and benefits. The Target Salary Range in the United States is $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.
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