Project Specialist
Core
Operational and administrative support for the setup, implementation, and management of Expanded Access Programs (EAPs) in clinical research.
Role type
Project Specialist (Clinical Research Operations)
Builds
Expanded Access Programs (EAPs) for sponsors and patients
Domain
Clinical Research / Healthcare
Deliverable
client delivery
Required skills
EAP setup and execution, eTMF management, CTMS data entry, supply chain coordination, vendor invoice filing, document organization (SharePoint/OneDrive), regulatory compliance (FDA/GCP/ICH), IPRF preparation, stakeholder communication
Preferred skills
Health or science degree background
Technologies
eTMF, CTMS, Microsoft Office, SharePoint, OneDrive
Responsibilities
Assist with EAP development and execution; coordinate investigational product shipments; file vendor invoices; maintain sponsor and site contact lists; communicate with sites for enrollment; organize program documents; review site documentation for compliance; prepare IPRFs; maintain data in CTMS.
Seniority
Junior to Mid-level, hands-on IC
