Lead Clinical Research Associate
Core
Lead a clinical study team to oversee trial activities, ensure compliance, and drive timely delivery at a country or regional level with minimal site assignments.
Role type
Senior Lead Clinical Research Associate (Regional/Country Level)
Builds
Clinical trials (Phase II/III) in Oncology, Cell Therapy, GI, and other therapeutic areas
Domain
Clinical Research / Contract Research Organization (CRO)
Deliverable
client delivery
Required skills
Clinical monitoring, data integrity, regulatory compliance, CAPA management, team leadership, project timeline management, risk management, supply chain management, audit coordination
Preferred skills
Oncology, Radiation Therapy, Cell Therapy, Gene Therapy, Nuclear Medicine, Gastroenterology (GI)
Technologies
MS Office
Responsibilities
Monitor project timelines, patient enrollment, and data cleaning; Review monitoring visit reports and ensure reporting compliance; 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 manage study risks; Ensure proper handling and reconciliation of investigational products; Review essential study documents and supervise ISF/TMF reconciliation; Coordinate safety information flow and protocol deviation reporting; Manage clinical supplies with vendors; Conduct supervised monitoring visits and site audit preparations; Mentor newly promoted Lead CRAs; Deliver trainings at Investigator Meetings; Ensure subject recruitment targets are met; Coordinate planning of monitoring visits; Manage site contracting and payments.
Seniority
Senior, hands-on IC with leadership responsibilities