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 and study data
Domain
Healthcare / Clinical Research
Required skills
Clinical trial oversight, team leadership, compliance management, data integrity, risk management, training and mentorship, supply chain management, audit coordination, stakeholder communication
Preferred skills
Experience with central monitoring, regulatory submission packages, investigator meetings
Technologies
Clinical tracking systems, TMF/ISF management tools
Responsibilities
Monitor project timelines, patient enrollment, and data cleaning; Review monitoring visit reports and ensure reporting compliance; Act as the main communication line between Monitors, Site Management Associates, and Project Managers; 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 Product(s) and clinical study supplies; Review essential study documents and supervise reconciliation of ISF/TMF; 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 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.
