Clinical Research Associate | Remote

Sonova Group; Santa Clarita (CA); Hybrid; USD 79,000 - 99,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k plan with company match

Paid parental bonding leave

Flexible Spending/Dependent Care

PTO and paid holidays

Tuition reimbursement

Hearing aid discount for employees and

Job summary

Sonova Group in Valencia, California is hiring a Clinical Research Associate to support global medical device clinical studies from start-up to close-out. You will work with investigative sites and cross-functional teams to ensure regulatory compliance and high-quality research in a hybrid environment.

The role requires 2+ years in clinical research, site monitoring experience, and proficiency with CTMS/EDC/eTMF.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or related field.
• 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.

Responsibilities

• Execute clinical studies from site start-up through study close-out in compliance with study protocols, ICH-GCP, ISO 14155, FDA regulations.
• Conduct site qualification, initiation, interim monitoring, and close-out visits (SQV, SIV, IMV, 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 elevate 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.

Skills

Clinical research experience

Independent site monitoring

Cross-functional collaboration

Time management

Fluent English

Education

Bachelor's degree in Life Sciences or related

Master's degree preferred

Tools

CTMS

EDC

eTMF

Job description

Valencia, California – Hybrid

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 role, 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 elevate 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.

More About You

• 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.

Preferred qualifications include: a 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; 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.

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: $79,000 – $99,000. This role is also bonus eligible.

How We Work

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.

Sonova is an equal opportunity employer. We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.