Clinical Research Associate (CRA) III

CVRx, Inc.; New York (NY); Remote; USD 127,000 - 142,000; Full time

Benefits offered by this job

Health insurance

401(k) match

Stock options/RSU grants

HSA contributions

Paid holidays

Job summary

CVRx, Inc. is seeking a Clinical Research Associate III (CRAIII) to manage day-to-day operations of clinical trials and monitor sites to ensure compliance with study protocols, SOPs, CVRx requirements, GCP, and regulatory rules. The role may work from a CVRx office or at sites as monitoring occurs.

This position involves traveling up to 40% within the US and coordinating with Clinical Project Managers, Data Management, Safety, Regulatory, and QA teams to ensure end-to-end study execution.

Qualifications

• Bachelor’s degree.
• 5+ years’ experience directly supporting clinical research of an implantable medical device or similar.
• 2 years’ experience in monitoring clinical trial sites.
• Deep knowledge of GCP’s and regulatory compliance guidelines for clinical trials.
• Excellent at managing multiple tasks and able to operate independently.
• Must be able to travel up to 40% within the US by car and air.

Responsibilities

• Develops and maintains successful working relationships with study sites and serves as the primary point of contact.
• Assists in preparation of study materials and training of investigators and site staff.
• Supports Clinical Centers in the execution of site IRB or ethics committee submissions.
• Collects and tracks required regulatory documents from various Clinical Centers as assigned.
• Coordinates and conducts monitoring at participating centers to ensure protocol compliance and timely data receipt.
• Prepares and submits high-quality monitoring reports per study-specific requirements.
• Evaluates site performance through enrollment trends, data quality, protocol deviations, product accountability, and patient safety parameters.
• Supports sites in AE/SAE identification, documentation, and reporting.
• Verifies timely submission of required safety documentation, device complaints, and follow-up queries.

Education

Bachelor's degree

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 mostly remote with travel to various sites across the southern US.
• Please note that if our ideal candidates reside near our headquarters in Brooklyn Park, MN we ask that you be open to occasional on-site visits to our HQ for meetings, as required.
• Travel: Please note that this position requires travel up to 50% as needed to support monitoring in sites across the US.

The Role

TheClinical Research AssociateIII(CRAIII) will be responsible for the day-to-day operations associated with the execution of clinical trials and monitoringthe clinical trial sitesto ensure they arecomplying to the applicable study protocol, Standard Operating Procedures (SOPs), CVRx requirements, GoodClinicalPractice (GCP), and the applicable regulatory requirement(s). The CRAIIIwill work closely withthe Clinical 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.

KEY DUTIES AND RESPONSIBILITIES

• 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.
• Collects and tracks required regulatory documents from various Clinical Centers as assigned.
• 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
• Evaluates site performance through analysis of enrollment trends, data quality metrics, protocol deviations, product accountability, and patient safety parameters.
• Supports sites in AE/SAE identification, documentation, and reporting.
• Verifies timely submission of required safety documentation, device complaint forms, and follow-up queries.
• Drives proactive risk identification at the site level and support the execution of risk-mitigation plans.
• Sources and verifiesclinical data/information and oversea data correction to 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.
• Works closely with Clinical Project Managers, Data Management, Safety, Regulatory, Quality, and Training to ensure end-to-end study execution.
• Provides operational input on protocol development, CRFs, risk assessments (RACT), monitoring plans, investigational brochures, and essential document requirements.
• Collaborates in Trial Master File (TMF) on quality checks to ensure site-level documentation is complete, audit-ready, and compliant.
• Contributes to process improvement initiatives, QMS updates, and clinical operations optimization.
• Assist management in metrics reporting, monitoring dashboards, and early risk detection through data analytics.
• Participates 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 other job-related duties as assigned.

REQUIRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE

• Bachelor’s degree
• Minimum of 5 years’ experience directly supporting clinical research of an implantable medical device or similar experience in a medical/scientific area
• Minimum of 2 years’ experience in monitoring clinical trial sites
• Deep knowledge of GCP’s and regulatory compliance guidelines for clinical trials
• Effective comprehension of medical terminology
• Ability to pay high level of attention to details and accuracy
• Excellent at managing multiple tasks and able to operate independently
• Manage tasks and duties in an efficient and expedient manner
• Maintains a high personal standard for ethics and integrity
• Contributing team player with excellence in working cross-functionally while maintaining high-performance standards
• Comfortable in a small company and able to thrive in a high-growth environment
• Sophisticated written and oral communications skills
• Effective problem-solving skills
• Adaptable, resourceful, and comfortable navigating change
• Entrepreneurial approach
• Must be able to travel up to 40% within the US by car and air
• Must possess valid government ID for domestic air travel (i.e. Passport, etc.)
• Must have valid license and reliable transportation
• Must have a professional home-office environment in which to perform work from home (when permitted) in a confidential and private manner

PREFERRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE

• Advanced degree in a related field is preferred

WORKING CONDITIONS AND REQUIRED PHYSICAL EFFORT

• Normal office conditions and a reliable high speed internet connection required when working in a home office
• Must be able to sit/stand/walk 8 hours per day
• Position requires up to 40% travel across the U.S.
• 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.

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 [e-mail]

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This requisition will be open until filled.