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Role Description

The Clinical Research Associate (CRA) supports the execution and oversight of feasibility, pivotal, and post-approval clinical investigations in accordance with FDA regulations, ISO 14155, ICH-GCP, and Sponsor standard operating procedures. The CRA is responsible for monitoring assigned investigational sites, ensuring protocol compliance, data integrity, and maintenance of inspection-ready documentation under the direction of the Senior Manager, Regulatory Clinical Research.

• Conduct qualification, initiation, interim monitoring, and close-out visits in accordance with the Monitoring Plan.
• Ensure investigational sites remain compliant with the approved protocol, regulatory requirements, and Sponsor SOPs.
• Perform source data review and verification to ensure accuracy, completeness, and traceability of clinical data.
• Review and ensure timely reporting of adverse events and device deficiencies.
• Support preparation of FDA Annual Reports and regulatory submissions as applicable.
• Maintain and reconcile TMF/eTMF documentation to ensure inspection readiness.
• Provide site training on investigational plan requirements and study procedures.
• Collaborate with Regulatory Affairs and Data Management to resolve data and compliance issues.
• Escalate protocol deviations, compliance concerns, or site performance issues as appropriate.
• Support internal and external audit readiness activities.

Qualifications

• Bachelor’s degree in Life Sciences or a related field, or an equivalent combination of relevant clinical research experience (post-baccalaureate degree preferred).
• Minimum 7+ years of clinical research experience, including experience with Phase I–IV clinical trials and/or medical device studies.
• Experience supporting clinical monitoring activities in a Sponsor or CRO environment, including managing monitoring from site initiation through close-out.
• Working knowledge of ICH-GCP guidelines, FDA regulations, and applicable clinical research standards (e.g., 21 CFR Parts 50, 54, 56, 812 and ISO 14155).
• Experience supporting IDE submissions, PMA-related studies, FDA Annual Reports, and regulatory inspections or audits.
• Demonstrated ability to identify and manage site compliance risks, maintain regulatory documentation, and ensure protocol adherence.
• Strong organizational, documentation, and communication skills with the ability to manage multiple sites and tasks within a regulated, cross-functional clinical research environment.
• A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova.

Requirements

• Willingness to travel up to 45%, primarily in North America.

Benefits

• Medical, dental and vision coverage*
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
• TeleHealth options
• 401k plan with company match*
• Company paid life/ad&d insurance
• Additional supplemental life/ad&d coverage available
• Company paid Short/Long-Term Disability coverage (STD/LTD)
• STD LTD Buy-ups available
• Accident/Hospital Indemnity coverage
• Legal/ID Theft Assistance
• PTO (or sick and vacation time), floating Diversity Day, & paid holidays*
• Paid parental bonding leave
• Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)
• Robust Internal Career Growth opportunities
• Tuition reimbursement
• Hearing aid discount for employees and family
• Internal social recognition platform

*Plan rules/offerings dependent upon group Company/location.

This role's pay range is between: $91,200/yr - $136,800/yr. This role is also bonus eligible.

Company Description

At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.