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Salary: USD 127,000 - 142,000 / annual
CVRx is seeking a Clinical Research Associate III to lead day-to-day operations and monitoring of clinical trials for implantable medical devices. This hybrid role is based in Brooklyn Park, MN, with up to 40-50% travel across US clinical trial sites.
You will serve as the primary point of contact for study sites, ensuring compliance with study protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, and regulatory requirements. Working closely with the Clinical Study Manager, you will oversee site operations and monitoring to meet project deliverables.
Key responsibilities include:
- Developing and maintaining relationships with clinical trial sites
- Preparing study materials and training investigators and site staff
- Supporting IRB/ethics committee submissions
- Collecting and tracking regulatory documents from clinical centers
- Conducting site monitoring visits to ensure protocol compliance and data quality
- Preparing high-quality monitoring reports per study specifications
- Evaluating site performance through enrollment trends, data quality metrics, protocol deviations, and patient safety parameters
- Supporting adverse event (AE/SAE) identification, documentation, and reporting
- Verifying timely submission of safety documentation and device complaint forms
- Identifying and mitigating site-level risks
- Source-verifying clinical data and overseeing data corrections
- Managing device accountability at sites
- Processing payments to sites, vendors, and consultants
- Collaborating with Clinical Project Managers, Data Management, Safety, Regulatory, Quality, and Training teams
- Providing operational input on protocol development, case report forms (CRFs), risk assessments, monitoring plans, and essential documents
- Ensuring Trial Master File (TMF) quality and audit-readiness
- Contributing to process improvement and clinical operations optimization
- Assisting with metrics reporting and early risk detection through data analytics
- Overseeing vendor compliance (central labs, imaging, core labs) as applicable
- Mentoring new Clinical Research Associates
- Completing special projects as assigned
Requirements:
- Bachelor's degree
- Minimum 5 years' experience directly supporting clinical research of implantable medical devices or similar medical/scientific experience
- Minimum 2 years' experience monitoring clinical trial sites
- Deep knowledge of GCP guidelines and regulatory compliance for clinical trials
- Effective comprehension of medical terminology
- High attention to detail and accuracy
- Ability to manage multiple tasks and operate independently
- Strong ethics and integrity
- Excellent cross-functional collaboration and communication skills (written and oral)
- Effective problem-solving abilities
- Adaptability and comfort with change in a high-growth environment
- Entrepreneurial mindset
- Ability to travel up to 40% within the US by car and air
- Valid government ID for domestic air travel (passport, etc.)
- Valid driver's license and reliable transportation
- Professional home-office environment for confidential work
Preferred:
- Advanced degree in a related field
