Lead Clinical Research Associate
Core
Lead a clinical research team to oversee study execution, ensure compliance, and drive trial activities at a country or regional level.
Role type
Senior Lead Clinical Research Associate (Regional/Country Level)
Builds
Clinical trials (Phase II/III) across various therapeutic areas
Domain
Clinical Research / Contract Research Organization (CRO)
Deliverable
client delivery
Required skills
Clinical trial monitoring, data integrity management, regulatory compliance, team leadership, project timeline management, risk management, source data verification, clinical supply management, audit coordination, training delivery
Preferred skills
Oncology experience, Cell Therapy/Gene Therapy/Radiopharmaceuticals experience, GI disease experience (Crohn's, UC, IBS), US site monitoring experience
Technologies
MS Office
Responsibilities
Monitor project timelines, patient enrollment, and data cleaning; review monitoring visit reports; act as communication liaison between monitors, sites, and project management; 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 clinical study supplies; review essential study documents and ISF/TMF; ensure data integrity and compliance; collaborate on site feasibility and 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 preparations and coordinate findings resolution; oversee CAPA development; mentor newly promoted Lead CRAs; deliver presentations at investigator meetings; ensure recruitment targets are met; manage document and supply flow between sites and labs; support regulatory and ethics committee submission packages
Seniority
Senior, hands-on IC with leadership responsibilities
