Clinical Research Associate

Location:

Remote or Redwood City, CA

Role Overview:

Serve as a primary resource for clinical research activities by providing site management support including developing and maintaining relationships with physicians, nurses, and research coordinators during the course of an active clinical study. Work within federal and ICH guidelines for clinical studies pertaining to informed consent, data monitoring, HIPPA, and regulatory filings to support clinical study approvals. Attend, train, and monitor clinical studies in compliance with approved protocol and relevant regulatory requirements.

Duties:

Independently manage day to day operations of Clinical & Data Management activities

Maintain oversight of site and vendor performance, deliverables, issues, their resolution and coordinate corrective actions as necessary

Conduct Site Initiation Visits, Monitoring Visits and Close-Out Visits as necessary

Conduct Site Qualification Visits as necessary

Drive clinical study enrollment in accordance with the study schedule

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