Associé(e) de recherche clinique senior
Core
Senior Clinical Research Associate acting as the primary liaison between AbCellera and clinical investigation sites to ensure patient safety, data integrity, and successful trial execution.
Role type
Senior Clinical Research Associate (Site Management & Monitoring)
Builds
Clinical trials for novel antibody-based drugs in endocrinology, women's health, immunology, and oncology.
Domain
Biotechnology / Clinical Research / Oncology
Deliverable
client delivery
Required skills
Strategic site monitoring, protocol deviation resolution, risk assessment, stakeholder management, regulatory compliance (ICH-GCP, FDA, EMA), site selection and initiation, data source verification, investigational drug management, mentorship.
Preferred skills
Training and mentoring other CRAs, audit preparation, recruitment strategy influence.
Technologies
ICH-GCP, FDA, EMA regulations
Responsibilities
Manage multiple complex investigation sites autonomously; oversee full monitoring lifecycle from selection to closure; verify source data and documentation; translate recruitment and quality metrics into actionable recommendations; manage investigational drug supply; resolve protocol deviations and compliance issues; anticipate study risks; train site personnel; mentor junior CRAs; prepare sites for sponsor and regulatory audits.
Seniority
Senior, hands-on IC with mentorship responsibilities