Clinical Research Associate

About the role

Join Advanced Bionics as a Clinical Research Associate and help support the successful execution of global medical device clinical studies from study start-up through close-out. In this hybrid role based in Valencia, California, you will work closely with investigative sites and cross-functional teams to support high-quality clinical research, maintain regulatory compliance, and contribute to studies that support innovative hearing healthcare technologies.

Responsibilities

• Execute clinical studies from site start-up through study close-out in compliance with study protocols, ICH-GCP, ISO 14155, FDA regulations, and applicable regulatory requirements.
• Conduct site qualification, initiation, interim monitoring, and close-out visits (SQV, SIV, IMV, and COV).
• Support site activation, investigator training, study device accountability, and study close-out activities.
• Serve as the primary operational contact for assigned investigative sites and monitor site performance, enrollment, protocol compliance, and data quality.
• Identify and escalate study risks and ensure timely resolution of monitoring findings, data queries, protocol deviations, and safety-reporting requirements.
• Maintain accurate and inspection-ready clinical documentation, including TMF/eTMF and investigator site files, and support audits and regulatory inspections.
• Collaborate with Clinical Trial Management and cross-functional partners to support successful study execution and regulatory submissions.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or another related scientific discipline.
• Minimum 2 years of clinical research experience, including at least 1 year 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.
• Strong organizational, communication, problem-solving, and time-management skills with the ability to independently manage multiple priorities.
• Fluent English communication skills, both written and spoken.
• Ability to travel approximately 30–50% to study sites, conferences, and other study-related activities.
• A minimum of 300Mb/sec download and 10Mb/sec upload speed internet connectivity to support remote/hybrid work.

Preferred Qualifications

• Master's degree or equivalent.
• ACRP-CRA, ACRP-CP, or SOCRA CCRP certification.
• Experience with Class III medical device clinical trials, global multicenter studies, FDA IDE/PMA or EU MDR clinical studies.
• Knowledge of Risk-Based Monitoring/RbQM.

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, and 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.

Pay

This role's pay range is between $79,000 – $99,000 and is bonus eligible.

Schedule

This is a hybrid role. The team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management.