Remote or Redwood City, CA
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.
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