Experienced CRA - Real World Evidence with SSU experience
Core
Perform monitoring, site management, and Site Start-Up (SSU) activities for Real World Evidence (RWE) studies, ensuring sites conduct studies and report data in accordance with protocols and regulations.
Role type
Clinical Research Associate (CRA) specializing in RWE and Site Start-Up
Builds
RWE studies, observational/non-interventional studies, and registry studies
Domain
Life sciences and healthcare
Required skills
Site monitoring, Site Start-Up (SSU), regulatory submissions, site activation, subject recruitment tracking, TMF/ISF management, remote site oversight, protocol adherence, data query resolution, financial management
Preferred skills
Real World Evidence (RWE) experience, observational study experience, registry study experience, post-authorization study experience
Technologies
Microsoft Word, Excel, PowerPoint, clinical research systems
Responsibilities
Perform site monitoring visits (selection, initiation, close-out), coordinate Site Start-Up activities, drive sites through start-up process, manage multiple sites and priorities, track subject recruitment plans, administer protocol training, evaluate site quality and integrity, manage study progress (submissions, activation, enrollment, data), maintain documentation (TMF, ISF), maintain remote oversight, collaborate with study team and stakeholders, support site financial management
Seniority
Mid-level, hands-on IC
