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Scientific. Clinical. Software Engineering

Part-Time (Remote) CRA Consultant

Maryland All, MD

Job Type: Clinical Job Number: JN -052020-26837 Region: Maryland All

Job Description

  • Clean patient data, participate in the clinical review of study data; create and/or resolve data queries as needed
  • Ensure timely collection/review of case report forms
  • Review reports and ensure timely resolution of issues
  • Track protocol violations and deviations ensuring appropriate documentation is available
  • Ensure SAEs are processed and closed in a timely manner and sites have followed their site-specific reporting requirements
  • Ensure also that SAE data is consistent with CRF data
  • Answer CRA study-related questions
  • Attend clinical team meetings and provide updates as needed (e.g. status of site visits, site/CRA issues, etc.)
  • Coordinate evaluation of site performance ensuring results are recorded in the investigator database
  • Monitor as needed to evaluate site adherence to protocols, review study progress, evaluate performance, provide monitoring support when needed, etc.

Requirements:

  • Requires a Bachelor s degree, R.N., or B.S.N. degree or equivalent
  • Minimum 5 years of independent monitoring experience from a pharmaceutical, biotech or CRO organization
  • Must have recent Gene Therapy monitoring experience


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