Job Description


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Clinical Research Associate – Monitor

  • Ref: 289445
  • Type: Direct Hire
  • Location: Stamford, CT
  • Industry: Biopharmaceuticals / Biotherapeutics
  • Job Level: Experienced Non-Manager
  • Pay: $110,000 - $115,000

Opportunity Description

We are currently seeking a Clinical Research Associate for an opportunity in Stamford, CT.

Job Duties

Primary Responsibilities:

  • Conduct oversight visits to assess CRO CRA and Investigational Site performance
  • Use experience and knowledge of ICH/GCP guidelines, protocols, Investigator’s Brochure, etc to identify issues and recommend solutions
  • Escalate critical issues to the Management team immediately, and communicate non-critical issues in a timely manner; ensure the CRO team are made aware of any trends that may affect multiple study sites and/or the study as a whole
  • Write oversight visit reports, providing feedback on identified issues, actions taken and/or proposed solutions.
  • Follow-up on identified issues by conducting additional oversight visits as needed and/or working with the CRO CRA and company/CRO management teams as needed to provide resolution
  • Re-train CRO CRAs and/or sites as needed

Secondary Responsibilities:

  • Provide co-monitoring assistance to CRO CRAs
  • Conduct pre-study visits, initiation visits, monitoring visits and/or close-out visits
  • Assist in study document creation/revision
  • Create training materials, conduct team trainings and/or present at Investigator Meetings
  • Create, maintain, and/or review spreadsheets and data listings
  • Conduct file audits

Experience & Skills Required

  • 5+ years of experience as a Clinical Research Associate
  • Therapeutic and/or clinical experience in chronic kidney disease and dialysis preferred.
  • Therapeutic and/or clinical experience in patient reported outcome, liver disease, and/or dermatological condition would be an advantage
  • Ability to work across multiple trials and multiple therapeutic indication
  • Ability to travel approximately 60-85%, regionally as feasible but across the US as needed
  • Detail-oriented with strong communication skills (oral and written) and ability to prepare accurate monitoring visit report quickly
  • Ability to be flexible and a team player is a must