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 and mentorship, risk management, project timeline management, source data verification, investigational product management, audit coordination, safety reporting, site contracting management
Preferred skills
Oncology, Radiation Therapy, Radiopharmaceuticals, CAR-T/Cell Therapy, Gene Therapy, Nuclear Medicine, Gastrointestinal disorders (Crohn's, Ulcerative Colitis, IBS)
Technologies
MS Office applications
Responsibilities
Oversee and guide the clinical team while driving trial activities at a country or regional level; 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; Provide project-specific training and prepare training materials; Supervise source data verification and manage study risks; Ensure proper handling and accountability of Investigational Products; Review essential study documents and supervise reconciliation of ISF/TMF; Coordinate safety information flow and protocol deviation reporting; Manage Monitors in the query resolution process; Conduct supervised monitoring visits and site audit preparations; Mentor newly promoted Lead CRAs; Deliver trainings at Investigator Meetings; Manage site contracting and payments; Coordinate CAPA development and implementation
Seniority
Senior, hands-on IC with leadership responsibilities
