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 trial execution and data integrity for Phase II/III studies
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, Investigational Product management, audit coordination, CAPA development
Preferred skills
Oncology, Cell Therapy (CAR-T, Gene Therapy), Nuclear Medicine, GI disorders (Crohn's, IBS), Radiation Therapy
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, site management, and project leads; 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 coordinate planning; Manage site contracting and payments; Conduct site audit preparation and coordinate resolution of findings; Oversee CAPA development and implementation; Mentor newly promoted Lead CRAs; Deliver trainings at Investigator Meetings; Ensure subject recruitment targets are met; Coordinate document and lab supply flow between sites and central labs; Support regulatory and ethics committee submission packages.
Seniority
Senior, hands-on IC with leadership responsibilities
