FSP Site Start Up Specialist
Core
Facilitate clinical trial site start-up by managing document collection, reviewing essential study documents, and coordinating with internal teams and CROs to ensure prompt site approval and adherence to study timelines.
Role type
Site Start-Up Specialist (Clinical Operations)
Builds
Clinical trial sites and study activation processes
Domain
Pharmaceutical industry / Clinical Research
Deliverable
client delivery
Required skills
Clinical trial site start-up management, Essential document review (ICF, FDF, 1572, CVs), CRO and Clinical Operations partnership, Study timeline tracking, eTMF management, FDA/ICH-GCP guidelines knowledge, Clinical Trial Agreement understanding, Budgeting and fair market value principles
Preferred skills
Pharmaceutical industry experience, Cross-functional collaboration, Data-driven decision making, Global ecosystem navigation
Technologies
Microsoft Excel, Microsoft Word, Microsoft PowerPoint
Responsibilities
Collect and review site essential documents for study start-up, Partner with Study Startup team, CROs, and Clinical Operations to improve start-up metrics, Track actions and communications to achieve study timelines, Escalate potential activation delays, Resolve escalated issues with CROs and Clinical Operations, Provide feedback on site performance metrics, Ensure accuracy and completeness of the eTMF
Seniority
Mid-level, hands-on IC