Lead Clinical Research Associate
Core
Oversees clinical trial monitoring, site management, and data integrity for global Phase I-III studies, ensuring regulatory compliance and patient enrollment targets.
Role type
Senior Lead Clinical Research Associate (Oncology/Cell Therapy focus)
Builds
Clinical trial operations and data quality for global studies
Domain
Clinical Research / Life Sciences / Oncology / Cell Therapy
Deliverable
client delivery
Required skills
Site monitoring, regulatory compliance (US/Canada), data integrity, project management, team leadership, CAPA management, site audit coordination, clinical supply management, training delivery
Preferred skills
Oncology, CAR-T/Cell Therapy, Gene Therapy, Radiation Therapy, Nuclear Medicine, GI disorders (Crohn's, UC, IBS)
Technologies
MS Office
Responsibilities
Coordinate investigator/site feasibility and study startup; monitor project timelines and patient enrollment; conduct and supervise monitoring visits; manage clinical supplies and Investigational Product accountability; ensure data integrity and compliance; lead project team calls and status reporting; prepare and conduct site audits; manage CAPA and protocol deviations; train monitors and site investigators.
Seniority
Senior, hands-on IC with team management
