Clinical Research Associate (CRA) II - hybrid in Minneapolis

CVRx, Inc. • Brooklyn Park, MN

7d • $85,000 - $105,000 • Hybrid

About The Position

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.

Requirements

• 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

Nice To Haves

• Advanced degree in a related field

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 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

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 restricted stock unit 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level