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Clinical Research Specialist

United States, United States · Healthcare
JOB TITLE:           Clinical Research Specialist
REPORTS TO:      Vice President of Operations and Product
STRUCTURE:       Full Time, Salaried
LOCATION:         Remote
 

FIVOS, Inc. provides technology and services for the healthcare industry to manage clinical information and utilize it to improve patient care quality and reduce costs. Powered by our advanced technological infrastructure and years of experience working in a regulatory environment, FIVOS is the leader in enterprise healthcare management solutions. 


Our company supports medical society quality improvement registries that collect real-world data that can be used to evaluate devices and medications. Current registries include the Vascular Quality Initiative (VQI) and the Neurovascular Quality Initiative (NNVQI), which focus on the treatment of peripheral and intracranial vascular disease. Data from these registries have been used to create multiple device evaluation projects required by manufacturers for regulatory purposes, including post-approval surveillance, label expansion, EU MDR requirements, objective performance goals, and control cases for new device comparison.  These activities often require the collection of additional data beyond the standard registry, provided through supplementary contracts with registry sites and custom data elements added to the registries.  We’re currently looking to add a new Clinical Research Specialist to the team. 


Summary
The Clinical Research Specialist will provide clinical and research trial expertise to this team.  In addition, the Clinical Research Specialist will serve as a general clinical advisor to other Fivos teams, with support from the Chief Medical Officer (CMO).

Responsibilities
  • Clinical Oversight of Device Evaluation Projects
    • Provide clinical support in the entire life cycle of the project, including the development of the proposal, documentation, the definition of custom work, project rollout, monitoring of data gathering and analysis, clinical design of reports for the industry sponsor, and project close
    • Manage the details of the project, including the following:
      • Participate in calls with device manufacturers with the CMO that are required to design a new project
        • Assist in the design of projects by working with the device manufacturer and CMO to match requirements with existing registry data elements and determine when custom variables are required
      • Assist Product Development in the design of reports
      • Monitor project progress, data completeness, and interact with the sites and sponsor regarding any questions or concerns that arise as data are reported and analyzed
      • Manage meeting of medical steering committees that are required for some projects, including preparation of slides to summarize data
      • Attend client calls for proposals and Change Orders with a clinical perspective
  • Assist with marketing material for Clinical Trials product line
  • Interact effectively with the Data Analyst to define project and reporting requirements
  • Maintain appropriate clinical expertise by literature review regarding new device or treatment types in the clinical areas represented by Fivos registries
     
  • Clinical Support for Other Fivos Teams
    • Based on clinical expertise, provide advice/education to the registry support team in response to customer questions about data entry
    • Assist with internal educational sessions when new registries or components are introduced
    • Respond to questions from sales staff during initial project inquiries
    • Generally, provide clinical support/advice in collaboration with the CMO

Requirements
  • Bachelor’s degree in nursing or other science major, associated with clinical experience related to vascular devices.   
  • 3+ Years of experience participating in clinical trials and/or clinical registries, either at a center, regulatory or manufacturer level
  • Ability to effectively interact remotely with other team members and to function independently with minimal supervision
  • Excellent verbal and written communication skills 
  • Excellent computer skills, including Google and Microsoft products
  • High attention to detail and accuracy
  • Excellent problem-solving, analytical, and interpersonal skills
  • Excellent organization and prioritization skills
  • High interest in continued self-education

We recognize that talented people are attracted to companies that provide competitive pay, comprehensive benefits package and outstanding advancement opportunities. For this reason, we offer a comprehensive benefits plan that includes the following:
  • 401K and Company match
  • Medical coverage
  • Dental coverage
  • Vision Coverage
  • Paid time off
  • Flexible spending accounts
  • Employee life insurance
  • Disability insurance

FIVOS is an Equal Opportunity Employer
 

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