Clinical Research Associate I/II (Anywhere US)


Category: CRA
Job #: 10620
Location: Anywhere US
Job Type: 1099
Rate / Salary Range: Competitive Hourly Rate

One of our Sponsor Clients is looking for a qualified CRA I or II to work remotely on study start-up.  The Sponsor is exhibiting a lot of growth, and the right individual could become a permanent part of an amazing Sponsor's team!

Job Responsibilities:
  • Assist in study start-up activities
  • Manage ongoing maintenance of eTMF
  • Create and Maintain study-specific eTMF management plans and lists in collaboration with document owners and the system administrator
  • Assess documents submitted to the eTMF and manage an assessment tracking tool
  • Manage corrective and/or preventive actions related to the eTMF to a satisfactory resolution
  • Coordinate with study teams to ensure timely submission of documents to regulatory authorities
  • Provide regular eTMF metric updates
  • Manage all eTMF inquiries and close-out of TMF-related issues
Job Qualifications:
  • One year’s experience in clinical research with study start-up experience consisting of at least 6 months is required
  • eTMF experience is required
  • Experience conducting with regulatory package review, collecting study documents, and working with an IRB is required
  • Some foundation in eDC and CTMS is required
  • Full-time (40 hours a week)
  • Competitive hourly rate

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