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 (Phase II/III) across various therapeutic areas
Domain
Clinical Research / Life Sciences
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 experience, GI disease experience, US site monitoring experience
Technologies
MS Office
Responsibilities
Monitor project timelines, patient enrollment, and data cleaning; Review monitoring visit reports and ensure reporting compliance; Act as main communication line between monitors, sites, and project management; Lead project team calls and provide status updates; Provide project-specific training and prepare training materials; Supervise source data verification and manage study risks; Ensure proper handling and reconciliation of investigational products and clinical supplies; Review essential study documents and supervise ISF/TMF reconciliation; Ensure data integrity and compliance at site level; Collaborate on site feasibility, identification, and study startup; Manage monitors in query resolution and central monitoring observations; Coordinate safety information flow and protocol deviation reporting; Manage clinical supplies with vendors; Coordinate planning and conduct supervised monitoring visits; Manage project team in site contracting and payments; Conduct site audit preparation visits and coordinate resolution of findings; Oversee CAPA development and implementation; Mentor newly promoted Lead CRAs; Deliver trainings at Investigator Meetings; Ensure subject recruitment targets and project timelines are met; Ensure accurate information flow regarding Adverse Events; Supervise Site Management Associates in document and supply flow; Support preparation of regulatory and ethics committee submission packages.
