Research Program Integrator
Core
Manage the end-to-end lifecycle of clinical research projects to develop OB AI products and secure FDA clearance.
Role type
Senior Research Program Integrator (Clinical Research)
Builds
FDA-cleared OB AI products via clinical research programs
Domain
Medical Devices / Clinical Research / FDA Regulatory
Deliverable
client delivery
Required skills
Clinical research program management, cross-functional team leadership, regulatory compliance (GCP, IRB, SOPs), budget and contract negotiation, study documentation, staff training, audit preparation
Preferred skills
PMP certification, clinical research certifications (CCRP, CCRA, CCRN)
Technologies
Clinical Trials Management System, MyWorkshop
Responsibilities
Oversee defined research activities to meet strategic needs; ensure compliance with study protocols and regulatory standards; lead cross-functional teams to deliver study outcomes; develop and maintain research documentation and regulatory binders; negotiate budgets and contracts with external partners; manage IRB submissions and adverse event reports; facilitate monitoring visits and prepare for audits.
Seniority
Senior, hands-on IC
