The Clinical Study and Regulatory Specialist I participates in the coordination of clinical trials from protocol review and approval through to activation, follow up and trial closure.DutiesMonitoring and promoting the quality and inte[...]
Evaluate, prepare and peer review of post approval supplements to manage the regulatory product life cycle as applicable. Review of change control documents. Approval of change control documents and quality notifications as assigned. A[...]
maintenance of regulatory binders and study documentation, some data entry tasks, and other departmental administrative tasks. The Clinical Trials Group operates in accordance with the trial protocol, hospital and departmental guidelin[...]