Principal Clinical Research Associate in Minneapolis, Minnesota at MicroTransponder

About Mobia Medical

Mobia Medical is a commercial-stage medtech company delivering breakthrough stroke recovery solutions. The company’s Vivistim® Paired VNS™ Therapy is the first and only FDA-approved implantable solution designed to improve function in chronic ischemic stroke survivors with moderate to severe upper limb impairments. Vivistim® Paired VNS™ Therapy combines targeted vagus nerve stimulation with functional movement to promote neuroplasticity and improve the brain’s ability to relearn motor skills. Mobia Medical is mobilizing patients, providers, and care partners to establish a better way forward in stroke care.

About the role

In this role, you will partner closely with Clinical, Regulatory, Medical Affairs, and cross-functional teams to ensure clinical studies are conducted with the highest standards of quality, compliance, and operational excellence. You will play a critical role in supporting feasibility, pivotal, and post-market studies while building strong relationships with investigational sites and ensuring the successful execution of clinical trial activities.

What you'll do

Lead clinical monitoring and site management activities

• Lead qualification, initiation, interim monitoring, and close-out visits for domestic and international clinical studies
• Build and maintain strong relationships with investigators, research coordinators, and site personnel
• Conduct site qualification and feasibility assessments to support study site selection
• Train investigators and site staff on protocols, investigational devices, EDC systems, and regulatory requirements

Drive clinical trial execution and operational excellence

• Support development and execution of clinical study plans, monitoring strategies, and enrollment initiatives
• Review site performance metrics and proactively address operational, compliance, enrollment, and data quality challenges
• Support site engagement and retention strategies to optimize study success
• Contribute to development of study documentation including monitoring reports, training materials, and study plans

Ensure data quality and regulatory compliance

• Ensure clinical studies are conducted in compliance with FDA regulations, ISO 14155, ICH-GCP, company SOPs, and study protocols
• Perform source data verification (SDV) activities and ensure data integrity
• Identify protocol deviations, safety concerns, and noncompliance issues and ensure appropriate escalation and resolution
• Support audit and inspection readiness activities

Collaborate cross-functionally

• Partner with internal stakeholders to achieve clinical and business objectives
• Provide leadership and mentoring within clinical operations activities
• Support communication and coordination across cross-functional teams involved in study execution

Qualifications

• Bachelor’s degree in life sciences, nursing, engineering, or related scientific discipline required
• Advanced degree preferred
• 8+ years of clinical research experience in medical device, biotechnology, or pharmaceutical industries
• 5+ years of independent clinical monitoring experience
• Experience supporting feasibility, pivotal, and/or post-market clinical studies
• Strong expertise in clinical monitoring, site management, and clinical trial operations

Preferred qualifications:

• Experience supporting multicenter clinical trials
• Strong knowledge of FDA regulations, ISO 14155, ICH-GCP, and global clinical regulations
• Experience with EDC systems, CTMS platforms, and Microsoft Office applications

You’ll thrive in this role if you are:

• A highly organized clinical professional who can manage multiple priorities in a fast-paced environment
• A strong communicator who builds trusted relationships with investigators and study teams
• Detail-oriented with a commitment to data quality and regulatory compliance
• A collaborative leader who works effectively across cross-functional teams
• Proactive in identifying risks and driving solutions to support successful study execution

Equal Opportunity Employer

Mobia Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Mobia Medical provides a comprehensive benefits program to employees. It includes medical, dental and vision plans along with an FSA. Employees may participate in the company 401(k) plan with company matching. The company offers an unlimited Paid Time Off (PTO) program and approximately 18 paid company holidays per year.

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