Clinical Research Associate (CRA) II - hybrid in Minneapolis in Brooklyn Park, Minnesota at CVRx, Inc.
Explore Related Opportunities
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 hybrid onsite at our Brooklyn Park, MN headquarters and our ideal candidate will reside locally.
The 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.
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
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
Creative and resourceful
Team player with high performance standards
Entrepreneurial approach
Advanced degree in a related field
Normal office conditions
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.