Clinical Research Associate - Cell Therapy
Core
Monitoring and managing the initiation, conduct, and close-out of complex cell therapy clinical trials to ensure compliance and data integrity.
Role type
Clinical Research Associate (Cell Therapy)
Builds
Clinical studies for life-changing medicines in oncology and other therapy areas
Domain
Biopharmaceuticals / Cell Therapy / Clinical Research
Deliverable
client delivery
Required skills
Independent clinical trial monitoring, site initiation and close-out, regulatory document preparation, source data verification, adverse event reporting, clinical trial management systems proficiency
Preferred skills
Knowledge of ICH-GCP guidelines, Australian regulatory requirements, life science background
Technologies
Clinical Trial Management System, electronic Trial Master File
Responsibilities
Contribute to investigator selection and site feasibility; Manage study start-up and regulatory maintenance; Train and support site staff on study requirements; Perform monitoring visits and data checks including Source Data Review and Case Report Form review; Report Serious Adverse Events and support audits
Seniority
Junior to Mid-level, hands-on IC