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Sr. Clinical Research Associate

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Location
MN
Job Type
Direct Hire
Date
Dec 03, 2018
Job ID
2643434
Our smaller medical device client is adding a Sr. Clinical Research Associate to the team. They are driven to improve and extend the life of patients suffering from neurological diseases by providing an innovative technology for patients with neurological diseases. The Sr. CRA will work with the Clinical Study Manager to satisfy applicable regulatory standards and internal requirements for worldwide clinical studies.  Bridges the responsibilities of the Clinical Study Coordinator and the Clinical Study Manager and focuses on study management activities, oversight of CRO’s, etc.

 
Your role with the company:
 
  • Assists with successful conduct of assigned studies consistent with R&D and Marketing plans.  This includes interfacing with representatives from key functional groups including Product Development, Manufacturing, Sales, Marketing, Distribution, and Regulatory Affairs.
  • Assists in preparation of study materials and training of investigators, center staff and field staff.
  • Writes the monitoring plan.  Coordinates and conducts monitoring at participating centers to ensure compliance with the protocol and regulations and the timely receipt of accurate data and other required study documents.
  • Reviews clinical data/information and oversees data correction.  Assists study managers in providing interim and final reports and presentations.
  • Provides input to study budgets and project plans.
  • Assists study manager by providing input to sections of Investigational Plan.
  • Assists study manager in writing Clinical Reports.
  • Takes initiative to oversee activities by Contract Research Organizations (CRO’s).
  • Assumes project management responsibility for smaller studies.
  • Has technical knowledge of products.
  • Assists study manager/statistician in writing of abstracts/manuscripts.
  • Reviews and approves center activation documentation.
  • Position requires at least 30% travel (once/twice a month for 1-2 days at a time monitoring clinical trial.)
Desired Profile:
  • Bachelor’s degree (technical or non-technical) Technical degree defined as engineering, biological sciences or related medical/scientific field.
  • Masters degree will substitute for 1 year of experience.  A Ph.D. or MD will substitute for 2 years of experience.
  • 3-5 years experience directly supporting clinical research.  Need to have 2+ years monitoring (will consider remote monitoring),
 
  • Able to manage multiple tasks.
  • Expertise with GCPs and regulatory compliance guidelines for clinical trials.
  • Knowledge of clinical and outcomes research study design.
  • Demonstrated ability to work effectively on cross-functional teams.