Senior Clinical Research Associate

Mansfield, MA

Join an established leader in the medical device diagnostic arena. Great team environment, career growth and competitive compensation package!

Responsibilities

  • Manage clinical trials, which may include protocol, ICF and CRF development, investigational product / supply management, budget / contract negotiation and regulatory document collection / management
  • Monitor clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs, utilizing knowledge of the diagnostic area sufficient to perform source data verification and monitor study protocol conduct / compliance; occasional handling of biological samples may be required
  • Assist clinical sites with IRB submission / documentation, as needed
  • Utilize a working knowledge of GCP and SOPs to assure compliance with FDA regulations and applicable processes and procedures
  • Anticipate and identify problems / issues and implement resolutions or provide recommendations for corrective actions in relevant job areas
  • Work cross-functionally with Regulatory Affairs and Quality Management as appropriate

Requirements

  • BS/BA in life science discipline or equivalent combination of education and experience
  • 5+ years of successful experience
  • CCRA certification with ACRP or SoCRA preferred
  • Experience in IVD and/or the medical device industry (will also consider pharma or hospital medical tech background)
  • Strong writing skills in all job responsibilities (e.g. protocols, monitoring reports, correspondence, clinical trial reports, etc.)
  • Effective verbal communication skills
  • Ability to travel, domestic and international (less than 10%)

Preferred Knowledge/Skills, Education, and Experience

  • Medical Technologist or equivalent laboratory background
  • Experience with Pre-Subs and 510k submissions

Inquiries and resumes to: Kathy Provost at kathy@agilesearchinc.com OR 978/952-6425

For more information, please visit www.agilesearchinc.com

Nov, 19, 2019

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