Lead Clinical Research Associate
Core
Lead a clinical research team to oversee trial activities, ensure compliance, and drive timely delivery at a country or regional level.
Role type
Senior Lead Clinical Research Associate (Regional/Country Level)
Builds
Clinical trials for pharmaceutical companies
Domain
Clinical Research / Life Sciences
Required skills
Clinical trial monitoring, data integrity management, regulatory compliance, team leadership, risk management, project planning, stakeholder communication, training delivery, supply chain management, audit coordination
Preferred skills
Oncology, gastroenterology, infectious diseases, autoimmune diseases, or rare disease indication experience
Technologies
MS Office applications
Responsibilities
Monitor project timelines, patient enrollment, and data cleaning; review monitoring visit reports; lead project team calls and provide status updates; provide training and prepare materials for the project team; supervise source data verification and data queries; manage Investigational Product and clinical study supplies; review essential study documents and ISF/TMF; ensure data integrity and compliance; collaborate on site feasibility and study startup; manage monitor query resolution; coordinate safety information flow and deviation reporting; manage clinical supplies with vendors; update tracking systems; coordinate and conduct supervised monitoring visits; manage site contracting and payments; conduct site audit preparation and coordinate findings resolution; oversee CAPA development; mentor newly promoted Lead CRAs; deliver presentations at Investigator Meetings; ensure recruitment targets and timelines are met; manage document and laboratory supply flow; support regulatory and ethics committee submission packages
Seniority
Senior, hands-on IC with leadership responsibilities
