Clinical Research Associate (CRA) III in Brooklyn Park, Minnesota at CVRx, Inc.
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Job Description
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 remote. Our ideal candidate will reside near our headquarters in Brooklyn Park, MN for occasional on-site visits.
TheClinical Research AssociateIII(CRAIII) will be responsible for the day-to-day operations associated with the execution of clinical trials andmonitoringthe clinical trial sitesto ensure they arecomplying to the applicable study protocol, Standard Operating Procedures (SOPs),CVRxrequirements, GoodClinicalPractice (GCP), and the applicable regulatory requirement(s).The CRAIIIwill work closely withtheClinical Study Manager to ensure siteday-to-day operations andmonitoring is executed to meet project deliverables. CRA III is expected to work from the CVRx office, or at the sites when monitoring.
Develops and maintains successful working relationships with study sites andserves asthe primary point of contact.
Assists in preparation of study materials and training of investigatorsand sitestaff
Supports Clinical Centers in the execution of site IRB or ethics committee submissions
Responsible for the collection and tracking of required regulatory documents from Clinical Centers
Coordinates and conducts monitoring (as directed by the monitoring plan) at participating centers to ensure compliance with the protocol and applicable regulations, as well as the timely receipt of accurate data and other required study documents
Prepares and submits high-quality monitoring reports per study-specific requirements
Evaluate site performance through analysis of enrollment trends, data quality metrics, protocol deviations, product accountability, and patient safety parameters
Support sites in AE/SAE identification, documentation, and reporting
Verify timely submission of required safety documentation, device complaint forms, and follow-up queries
Drive proactive risk identification at the site level and support the execution of risk-mitigation plans
Source verifiesclinical data/information and oversees data correctionto match source
Maintains Clinical Study files
Manages device accountability at site(if applicable)
Processes payments to sites, vendors, and consultants
Reviews clinical data/information and oversees data correction
Reviews center activation documentation
Work closely with Clinical Project Managers, Data Management, Safety, Regulatory, Quality, and Training to ensure end-to-end study execution
Provide operational input on protocol development, CRFs, risk assessments (RACT), monitoring plans, investigational brochures, and essential document requirements
Collaborate in Trial Master File (TMF) quality checks to ensure site-level documentation is complete, audit-ready, and compliant
Contribute to process improvement initiatives, QMS updates, and clinical operations optimization
Assist management in metrics reporting, monitoring dashboards, and early risk detection through data analytics
Participate in vendor oversight (central labs, imaging, core labs) to ensure site compliance (if applicable)
Assists in training new Clinical Research Associates
Assists with successful conduct of assigned studies. This includes interfacing with representatives from key functional groups including Regulatory Affairsand Quality Assurance,Research & Development, U.S. Market Development, Commercial Developmentand Clinical Research Organizations
Provides mentoring regardingsitemonitoringto internal team
Completes special projects and performs job-related duties as assigned
Bachelor’s degree
5+ years experience directly supporting clinical research or similar experience in a medical/scientific area
2+ years experience in monitoring clinical trial sites
Knowledge of GCP’s and regulatory compliance guidelines for clinical trials
Knowledge of medical terminology
High attention to detail and accuracy
Able to manage multiple tasks and operate independently
Operates in an efficient and expedient manner
High ethical standards and integrity
Strong team player with experience working cross-functionally and maintaining high-performance standards
Comfortable in a small company and thrives in a high-growth environment
Advanced written and oral communications skills
Good problem-solving skills
Adaptable, resourceful, and comfortable navigating change
Entrepreneurial approach
Advanced degree in a related field is preferred
- Normal office conditions and a reliable internet connection when working in a home office
- Must be able to sit/stand/walk 8 hours per day
- Position requires up to 40% travel
- May be required to be fully vaccinated against the COVID-19 virus and other diseases
CVRx is unable to provide employment visa sponsorship for this position. Candidates must be legally authorized to work in the United States without current or future sponsorship
What we offer:
CVRx is proud to offer competitive salaries and benefits plans.
We offer a culture of teamwork, collaboration, and positivity, where challenging the status quo is welcomed, continuous learning is valued, and each of us has an opportunity to make a significant impact in an exciting, purpose-driven startup environment while also having fun.
Salary range for U.S locations (USD): 127,000 - 142,000 per year.
The pay range is applicable across the U.S., complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and specific location.
We also offer a competitive and rewarding benefits package, details listed below:
- Competitive Health & Dental Insurance options with generous Company contributions
- Company contributions to an HSA with a high deductible insurance plan selection
- 401(k) with a company match
- Employee stock purchase plan (ESPP) & stock option and RSU grants
- 12 company-paid holidays per year in addition to a generous Flex PTO plan
- Generous paid time off for new parents
- Company-paid life insurance & disability options
- Unlimited growth opportunities in a growing company
- Endless training & learning opportunities
- Flexible Schedule
EEO STATEMENT
CVRx, Inc. 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.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
If you're an independent, self-motivated individual with excellent interpersonal skills, a desire to do great things and have a background in medical devices, healthcare or a related field, we want to hear from you!
If you need assistance or an accommodation due to a disability, you may contact us at hiring@cvrx.com
This requisition will be open until filled.