Study Start-Up Manager
Core
Manage study start-up and site activations for the TIME clinical trials network to increase patient access to clinical trials in community settings.
Role type
Study Start-Up Manager
Builds
Clinical trial activations and patient enrollment pathways
Domain
Healthcare / Clinical Research / Oncology
Deliverable
client delivery
Required skills
Study start-up management, site activation coordination, IRB review facilitation, FDA regulations knowledge, GCP compliance, HIPAA compliance, project management, feasibility analysis
Preferred skills
JIT study start-up experience, CCRC certification
Technologies
MS Office (Outlook, Word, Excel, PowerPoint)
Responsibilities
Act as single point of contact for JIT and expedited site activations; Coordinate with TIME sites and sponsor teams to activate clinical trials; Collaborate with central IRB team to facilitate review and approval; Educate TIME sites and sponsor partners on activation processes; Contribute to relationships with TIME sites and pharmaceutical/CRO partners; Develop and implement new workflows to drive efficiencies; Support team performing feasibility and activation activities
Seniority
Mid-level, hands-on IC
