Trial Activation Approval Specialist I

Work Schedule

Environmental Conditions

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.