Senior Clinical Research Associate Valencia, California - REMOTE FOR THE RIGHT CANDIDATE
Join Advanced Bionics as a Senior Clinical Research Associate and take a lead role in the operational execution of global medical device clinical studies from study start-up through close-out. You will manage complex investigative sites, drive study quality and performance, identify and mitigate operational risks, and serve as an experienced clinical operations resource to study teams while helping advance innovative hearing healthcare technologies.
Responsibilities- Independently lead the operational execution of assigned global clinical studies from site start-up through close-out in accordance with study protocols, ICH-GCP, ISO 14155, FDA regulations, and applicable international regulatory requirements.
- Conduct site qualification, initiation, interim monitoring, and close-out visits (SQV, SIV, IMV, and COV) for complex or high-priority studies.
- Lead site activation, investigator training, study device accountability, close-out planning, and other activities required to achieve study milestones.
- Serve as the primary operational lead for assigned investigative sites, monitoring enrollment, site performance, protocol compliance, and data quality while proactively identifying and mitigating risks.
- Independently resolve complex monitoring findings, protocol deviations, data queries, and site-performance issues while escalating significant risks with recommended solutions.
- Maintain inspection-ready TMF/eTMF and investigator site documentation, support audits and regulatory inspections, and promote consistent application of clinical quality standards.
- Partner with Clinical Trial Management, Data Management, Biostatistics, Regulatory Affairs, Quality, Medical Affairs, and external vendors while mentoring CRAs and supporting clinical operations process improvements.
More about you- Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or another related scientific discipline.
- Minimum 5 years of clinical research experience, including at least 2 years of independent site monitoring.
- Experience managing multiple clinical sites and working with CTMS, EDC, and eTMF systems.
- Strong knowledge of ICH-GCP, ISO 14155, FDA regulations, clinical monitoring, site management, and data quality.
- Demonstrated ability to independently manage complex studies, multiple priorities, operational risks, and site-performance challenges.
- Strong organizational, communication, problem-solving, and time-management skills.
- Ability to travel approximately 30-50% to study sites, conferences, and other study-related activities.
Preferred qualifications include: a Master's degree or equivalent; ACRP-CRA, ACRP-CP, or SOCRA CCRP certification; experience in Class III medical device clinical trials, global multicenter studies, FDA IDE/PMA or EU MDR clinical studies; experience mentoring junior CRAs or leading monitoring activities; and knowledge of Risk-Based Monitoring/RbQM.
A minimum of 300Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova.
Don't meet all the criteria? If you're willing to go all in and learn we'd love to hear from you!
We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app, telegram, carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone please contact Sonova Human Resources.
What we offer- 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: $100,000 - $125,000. This role is also [bonus eligible/commission eligible, if applicable].
How we workAt 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.
