Principal Clinical Research Associate

Mobia Medical • Minneapolis, MN

3d

About The Position

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.

Requirements

• Bachelor’s degree in life sciences, nursing, engineering, or related scientific discipline required
• 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

Nice To Haves

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

Responsibilities

• 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

Benefits

• medical
• dental
• vision plans
• FSA
• 401(k) plan with company matching
• unlimited Paid Time Off (PTO)
• approximately 18 paid company holidays per year

What This Job Offers

• Job Type: Full-time
• Career Level: Principal