Trial Activation Approval Specialist I Job at Thermo Fisher Scientific, Cornelius, NC

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  • Thermo Fisher Scientific
  • Cornelius, NC

Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

  • Facilitate site start-up and communication with internal and external team members to ensure flawless site approval and study timelines.
  • Support sites and study teams to achieve rapid site start-up.
  • Work directly with assigned sites on all essential document collection and review.
  • Partner with internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve overall SSU metrics and processes.
  • Ensure standards are strictly applied to the SSU processes across projects.
  • Review essential documents for start-up including ICF, FDF, 1572, CVs, etc.
  • Quickly identify potential site activation delays and bring up to appropriate team members.
  • Track actions and communications with sites to ensure timelines are met.
  • Support resolving advanced issues identified by CROs and Clinical Operations teams in partnership with the internal Study Startup team.
  • Review and provide feedback to management on site performance metrics.
  • Ensure accuracy and completeness of the eTMF for assigned sites during start-up.

Thermo Fisher Scientific

Job Tags

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