Clinical Research Associate (CRA) II - hybrid in Minneapolis

CVRx · Brooklyn Park, MN

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 Role

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.  

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

  • Creative and resourceful

  • Team player with high performance standards

  • Entrepreneurial approach

PREFERRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE

  • Advanced degree in a related field

 
 

WORKING CONDITIONS AND REQUIRED PHYSICAL EFFORT

  • 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.

Clinical Research pay context

Based on 135 disclosed Clinical Research salaries on RoleSuite, the role pays a median of $140K/year, with most offers between $96K and $163K (10th–90th percentile: $65K–$238K).

See the full Clinical Research salary breakdown →
Apply →

Other roles at CVRx

More Clinical Research roles