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Remote Clinical Research Associate - IVD (Science & Biotech)
Durham, NC 27710
Recruited by: Lori Steiner | Principal and Owner | NeedLS See all my Jobs

  • Hiring Company: NeedLS
  • Industry: Science & Biotech
  • Compensation: to be determined
  • Expires: Dec 26, 2019
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Job Description

Perform site monitoring duties assigned for one or more trials.
Participate in Study-specific training program, including review key study documents, participate in training sessions
Conduct pre-study site qualification visits
Conduct on-site study initiation visits to inspect and inventory clinical supplies, review protocol, AE reporting, Site Files, eCRFs and other study related documents
Conduct on-site monitoring visits
Participate in site escalation process as needed, including root cause analysis, CAPA, and follow through to resolution.
Communicate with PI between visits
Conduct on-site close out visit. Resolve queries, Drug return,
Prepare all applicable visit documentation per specific visit type

BS Degree in technical/scientific discipline, or AS with 5 yrs min directly related to clinical research
5+ yrs as a CRA
2+ yrs monitoring multiple studies simultaneously
Direct experience monitoring IVD studies
Prior CRO experience.