Clinical Research Manager

5 days ago


South San Francisco, California, United States Solomon Page Full time
About the Role

The Senior CTA will provide key support to the clinical study team to plan, implement, and complete in-house and outsourced studies. This includes working with investigative sites and vendors, reviewing and processing clinical study-related documents, and maintaining eTMF.

Responsibilities
  • Provide key support to the clinical study team to ensure successful planning, implementation, and completion of in-house and outsourced studies.
  • Work with investigative sites and vendors to provide support and ensure timely delivery of study materials.
  • Review and process clinical study-related documents, including Clinical Visit summaries, protocols, FDA 1572s, lab certifications, IRB approvals, and more.
  • Maintain and update Visit Reports, Regulatory Documents, site and team contact lists, vendor lists, and more.
  • Prepare agendas and take comprehensive minutes for meetings.
  • Study level tracking, including monitor visit tracking, sample tracking, and study-related supplies.
  • Help prepare materials for investigator meetings, monitor workshops, and study manuals.
  • Ensure completed documents are provided to the Regulatory Affairs group.


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