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Clinical Research Associate

Title:                     Clinical Research Associate

Location:            Nashua, NH

 

Company

Conformal Medical was started in 2016 to develop the next generation of left atrial appendage occlusion implants used to prevent strokes in patients with Atrial Fibrillation (AFib). The CLAAS® System is an innovative technology that simplifies the procedure, improves the patient experience, and may improve outcomes. The company has completed first-in-human trials and is preparing for US pivotal clinical trials.

The Clinical Research Associate is a key member of the clinical affairs team and is responsible for the day-to-day management of clinical trial execution. The individual will also interface with the internal Conformal Regulatory, Quality, and Engineering teams to ensure a fully integrated multi-functional team is supporting the clinical trials.

 

Responsibilities

  • Provides operational support of clinical trial sites
  • Performs study protocol training to investigators and study staff team
  • Conducts and/or supports qualification, site initiation, interim and close-out visits
  • Supports enrollment strategy (i.e. develop advertising materials)
  • Supports data cleaning efforts through EDC query and data review
  • Coordinates shipment of investigational product
  • Submits study documents to Institutional Review Boards
  • Attends study team meetings and maintains meeting agenda, minutes
  • Supports review of clinical trial agreements and vendor agreements
  • Supports management of investigational site invoice processing
  • Assists with the review and maintenance of departmental SOPs
  • Supports the maintenance of the Trial Master File documents

 

Qualifications

  • A minimum of 5 years of medical device Clinical Affairs experience.
  • A history of site management experience is a must
  • BS degree in a technical discipline (eg biology, chemistry, engineering).
  • Experience in Microsoft Office
  • Experience with electronic database capture (EDC) platforms
  • Good communication with all levels of the company, hospitals, and physicians.
  • Travel 75%

 
If interested, please contact info@conformalmedical.com