Clinical Research Associate (CRA) III (Hybrid)

CVRx•Brooklyn Park, MN

7d•Hybrid

About The Position

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. Please note that our ideal candidates will reside near our headquarters in Brooklyn Park, MN and be open to occasional on-site visits for meetings as required. Please note that this position requires travel up to 50% as needed to support monitoring in sites across the US. The Clinical Research Associate III (CRA III) will be responsible for the day-to-day operations associated with the execution of clinical trials and monitoring the clinical trial sites to ensure they are complying to the applicable study protocol, Standard Operating Procedures (SOPs), CVRx requirements, Good Clinical Practice (GCP), and the applicable regulatory requirement(s). The CRA III will work closely with the Clinical Study Manager to ensure site day-to-day operations and monitoring is executed to meet project deliverables. CRA III is expected to work from the CVRx office, or at the sites when monitoring.

Requirements

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

Nice To Haves

Advanced degree in a related field is preferred

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.
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 verifies clinical data/information and oversees 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.
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 Affairs and Quality Assurance, Research & Development, U.S. Market Development, Commercial Development and Clinical Research Organizations.
Provides mentoring regarding site monitoring to internal team.
Completes special projects and performs job-related duties as assigned.

Benefits

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