Senior Clinical Research Associate | REMOTE

Sonova AG

1d•$91,000 - $114,000•Hybrid

About The Position

Advanced Bionics is seeking a Senior Clinical Research Associate to lead the operational execution of global medical device clinical studies from study start-up through close-out. The role manages complex investigative sites, drives study quality and performance, identifies and mitigates operational risks, and serves as an experienced clinical operations resource to study teams while supporting the advancement of hearing healthcare technologies. The position is based in Valencia, California, with remote work available for the right candidate; West Coast candidates are preferred. The role includes site qualification, initiation, interim monitoring, and close-out visits, as well as site activation, investigator training, study device accountability, and close-out planning. The Senior Clinical Research Associate serves as the primary operational lead for assigned sites, maintains inspection-ready TMF/eTMF and investigator site documentation, supports audits and regulatory inspections, and collaborates with internal functions and external vendors. Travel to study sites, conferences, and other study-related activities is approximately 30–50%. Remote or hybrid employees must have internet connectivity of at least 300 Mb/sec download and 10 Mb/sec upload. The pay range is $91,000–$114,000, depending on location and experience. Sonova describes a team-customized hybrid work model that supports flexibility, individualized time management, employee well-being, engagement, and collaboration.

Requirements

Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or another related scientific discipline.
At least 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.
For remote or hybrid employee functionality, internet connectivity of at least 300 Mb/sec download and 10 Mb/sec upload.

Nice To Haves

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 studies, or EU MDR clinical studies.
Experience mentoring junior CRAs or leading monitoring activities.
Knowledge of Risk-Based Monitoring/RbQM.

Responsibilities

Independently lead assigned global clinical studies operationally 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 needed to achieve study milestones.
Serve as the primary operational lead for assigned investigative sites, monitoring enrollment, site performance, protocol compliance, and data quality while identifying and mitigating risks.
Resolve complex monitoring findings, protocol deviations, data queries, and site-performance issues, 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.
Mentor CRAs and support clinical operations process improvements.

Benefits

Medical, dental, and vision coverage.
Health Savings, Health Reimbursement, Flexible Spending, and Dependent Care Accounts.
TeleHealth options.
401(k) plan with company match.
Company-paid life/AD&D insurance, with additional supplemental life/AD&D coverage available.
Company-paid short- and long-term disability coverage, with buy-up options available.
Accident/Hospital Indemnity coverage.
Legal/ID Theft Assistance.
PTO or sick and vacation time, floating Diversity Day, and paid holidays.
Paid parental bonding leave.
Employee Assistance Program, including a 24/7 mental health support hotline and five company-paid counseling sessions.
Internal career growth opportunities.
Tuition reimbursement.
Hearing aid discount for employees and family.
Internal social recognition platform.