Trial Activation Approval Specialist I
Thermo Fisher Scientific
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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.
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