Logo for CVRx | Barostim

Clinical Research Associate (CRA) II

CVRx | Barostim

Role overview

Qualifications

  • 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

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
  • Coordinates and conducts monitoring at participating centers to ensure compliance with protocol, regulations, and the timely receipt of accurate data

Key facts

Hard skills

Clinical Trial Management Systems Good Clinical Practices (GCP) Regulatory Compliance Project Management Budget Management Cross-Functional Collaboration

Other skills

  • Mentorship
  • Training And Development
  • Research
  • Communication
  • Problem Solving
  • Detail Oriented
  • Teamwork
  • Adaptability
  • Creativity
  • Personal Integrity

About the company

CVRx | Barostim logo

CVRx | Barostim

CVRx is a commercial stage, public (NASDAQ: CVRX) medical devices company located in Minneapolis, Minnesota. The company has developed proprietary implantable technology for the treatment of high blood pressure and heart failure. Barostim™ triggers carotid baroreceptors - the body’s own natural blood flow regulation system - which signals the brain to regulate cardiovascular function. Patient Stories on CVRx: The accounts and quotes of patients are genuine and documented. These stories represent a unique individual experience and does not provide any indication, guide, warranty or guarantee as to the response other people may have to CVRx technologies. Barostim is a prescriptive device. For a list of all potential benefits and risks go to www.cvrx.com/benefit-risk-analysis/

Company details

Company typeSME
Company size51 - 200

Links

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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 remote. Our ideal candidate will reside near our headquarters in Brooklyn Park, MN for occasional on-site visits.  

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.

CVRx is unable to provide employment visa sponsorship for this position. Candidates must be legally authorized to work in the United States without current or future sponsorship
 
 
What we offer:
CVRx is proud to offer competitive salaries and benefits plans.
 
We offer a culture of teamwork, collaboration, and positivity, where challenging the status quo is welcomed, continuous learning is valued, and each of us has an opportunity to make a significant impact in an exciting, purpose-driven startup environment while also having fun.
 
Salary range for U.S locations (USD): 85,000 - 105,000 per year.
 
The pay range is applicable across the U.S., complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and specific location. 
 
We also offer a competitive and rewarding benefits package, details listed below:
* 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
 
EEO STATEMENT
CVRx, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. 
 
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.  
 
If you're an independent, self-motivated individual with excellent interpersonal skills, a desire to do great things and have a background in medical devices, healthcare or a related field, we want to hear from you!   
 
If you need assistance or an accommodation due to a disability, you may contact us at hiring@cvrx.com 
 
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Marcus Rivera

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