Clinical Research Associate (CRA) II

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.

The RoleThe Clinical Research Associate (CRA) II performs the day-to-day operations associated with the execution of clinical trials and is responsible for the direct contact with assigned clinical investigative sites. The CRA II will coordinate site activities from site start-up to site closure as needed. The CRA II will ensure the overall quality of the clinical sites by reviewing study data and managing site adherence to the protocol, Good Clinical Practice (GCP), and all applicable regulations. The CRA II will work closely with the other CRAs on the clinical team and project managers to ensure the sites maintain compliance.

KEY DUTIES AND RESPONSIBILITIES

• Proactively maintains timelines for assigned or requested deliverables
• Develops and maintains successful working relationships with study sites and CVRx field staff
• Assists in preparation of study materials and training of investigators and research site staff
• Becomes proficient with all study databases, systems and company quality management system
• Reviews and verifies clinical data/information and oversees data correction to match source
• Acts a site manager and monitor to assigned sites as applicable per study requirements
• Processes payments to sites, vendors, and consultants. Supports the Clinical Project Manager with study finance activities and tracking
• Supports Clinical Centers in the execution of site Institutional Review Board (IRB) or ethics committee (EC) submissions
• Responsible for the collection, tracking, and maintaining required study and regulatory documents from clinical centers through all phases of assigned projects
• Prepares study materials and trains investigators and site staff
• Responsible for shipment of study-related materials as applicable
• Coordinates and conducts monitoring (as directed by the monitoring plan) at participating centers to ensure compliance with protocol, regulations, and the timely receipt of accurate data / other required study documents
• Reviews and verifies clinical data/information and oversees data correction to match source
• Reviews monitoring reports
• Manages device accountability at site (if applicable)
• Provides input to study budgets and project plan
• Contributes to maintaining oversight of activities conducted by Contract Research Organizations (CRO’s) or other contractors on behalf of CVRx (if applicable)
• Assists in training or mentorship of new Clinical Research Associates
• Completes special projects and performs job-related duties as assigned

REQUIRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE

• Bachelor’s degree or advanced degree in science or a related field, or equivalent work experience
• 2-4 years experience directly supporting clinical research or similar experience in a medical/scientific area
• Knowledge of medical terminology
• Experience with GCP’s and regulatory compliance guidelines for clinical trials
• High attention to detail and accuracy
• Ability to manage multiple tasks and operate independently
• Operates in an efficient and expedient manner
• High ethical standards and integrity
• Experience working on cross-functional teams
• Comfortable in a small company and thrives in a high-growth environment
• Advanced written and oral communications skills
• Good problem-solving skills
• Adaptable and embraces change