Why work for CVRx?

CVRx pioneers' unique therapies that harness and harmonize the body’s natural systems, benefiting society and making CVRx a universal role model in healthcare. We value our commitments to others and continue to overcome challenges through determination, collaboration and purpose. If our culture and values speak to you, and if you have a passion for cutting-edge medical technologies, join our team and our mission to help others live better lives.

This position is hybrid onsite at our Brooklyn Park, MN headquarters and our ideal candidate will reside locally.  

Why work for CVRx?

CVRx pioneers' unique therapies that harness and harmonize the body’s natural systems, benefiting society and making CVRx a universal role model in healthcare. We value our commitments to others and continue to overcome challenges through determination, collaboration and purpose. If our culture and values speak to you, and if you have a passion for cutting-edge medical technologies, join our team and our mission to help others live better lives.

This position is hybrid onsite at our Brooklyn Park, MN headquarters and our ideal candidate will reside locally.  

Why work for CVRx?
CVRx pioneers' unique therapies that harness and harmonize the body’s natural systems, benefiting society and making CVRx a universal role model in healthcare. We value our commitments to others and continue to overcome challenges through determination, collaboration and purpose. If our culture and values speak to you, and if you have a passion for cutting-edge medical technologies, join our team and our mission to help others live better lives.
 
This role is full-time onsite at our Brooklyn Park, MN headquarters and our ideal candidate is local to the Minneapolis area. 
 
The Role
Provide hands-on quality engineering support activities for supporting the design, development, manufacturing and post- market surveillance activities for CVRx products. This position partners cross-functionally with R&D, Operations, Regulatory, and Clinical teams to support product quality, process improvements, investigations, validations, and continuous improvement activities to ensure compliance with applicable regulations and standards, with particular attention to risk management activities.  


KEY DUTIES AND RESPONSIBILITIES

Maintain and organize clinical trial documentation, including study files, essential documents, and correspondence.

Assist in the collection and tracking of study documents.

Maintains the Trial Master File (TMF) to ensure inspection-readiness at all times, including quality control review of documents to ensure compliance with GCP.

Track and follow-up on outstanding site documentation and administrative requirements.

Assist with data reconciliation, and maintenance of administrative and operational data within clinical trial systems

Prepare and distribute meeting agenda’s, meeting minutes, and action items to Clinical team.

Update TMF, CTMS, EDC management systems, when needed.

Assists in trial activities such as processing payments, running reports, tracking study deliverables as needed.

Maintaines trial related trackers, logs and internal dashboards,

Support study start-up activities, including review and maintence of regulatory document and site initiation materials.

Perform ad-hoc and cross-functional duties and/or projects, as assigned by manager or supervisor

REQUIRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE

• Bachelor’s Degree (health or life sciences preferred)
• 1-2 years experience in clinical research operations support
• Knowledgeable in FDA regulations, ISO 14155 and GCP
• Experience working in Electronic Trial Master File (eTMF) Systems (e.g. Florence).
• Experience working in Electronic Data Capture (EDC) Systems (e.g. iMednet).
• Excellent interpersonal, verbal, and written communication skills, with the ability to effectively work across departments with diverse needs
• Excellent organizational and time management skills
• High work standards and ethics and a passion for success
• High attention to detail and emphasis on accuracy
• Ability to work in a team environment
• Proficient in Microsoft Office Suite (Office 365)

PREFERRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE

Prior experience with cardiovascular medical device research studies

Prior experience working with disruptive medical devices

Prior experience in a growth or start-up stage company

WORKING CONDITIONS AND REQUIRED PHYSICAL EFFORT

Normal office conditions

Must be able to sit/stand/walk 8 hours per day.

Ability to travel for business as required up to 10% by car and/or air