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Sr. Clinical Research Associate

Location: San Diego, California Salary: competitive
Sector: Clinical Research Type: Contract

Job Tasks:

  • Co-monitor site pre-study, initiation, routine monitoring, and study closeout visits with CSP CRA to assess CSP and site performance for studies managed by a CRO.
  • Review all study monitoring tasks at study sites to ensure compliance with GCP, ICH, applicable regulations and company SOPs for CRO managed clinical trials.
  • Assist with the collection, review and, tracking of site-specific study/essential documents.
  • Performs ongoing reconciliation of the Trial Master File (TMF) with content from site files.
  • Provide training to site personnel and CSP CRA personnel, as required
  • Tracks and reports progress of study sites.
  • For CRO managed trials, assists with timely reconciliation of data queries and implementation of process improvement/corrective action when needed.
  • Participates in the development and review of source documents, Case Report Forms, edit checks, and may participate in User Acceptance Testing for various systems used in Clinical Research.
  • Coordinates, assembles, and ship study related supplies as needed.
  • Assists with creation and review of study tools/documents.
  • Will require approximately 40% business travel internationally

Requirements:

  • CNS experience a plus
  • Knowledge of GCP/FDA/ICH regulations required.
  • Have an extensive and broad understanding of clinical research.
  • Have a working knowledge of the relevant SOPs.
  • Have strong interpersonal and communication skills
  • Attention to detail with the ability to prioritize and multi-task.
  • Must have strong organizational skills
  • Ability to work well under pressure and with tight schedules.
  • must be proficient in MS Word and Excel,

Sthree US is acting as an Employment Business in relation to this vacancy.