Essential Responsibilities and Duties: Assist the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines Review follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis Perform ongoing review of a percentage sampling of study inclusion/exclusion, study procedure records, and laboratory reports to ensure that they are conducted according to the protocol, applicable SOPs, ICH/GCP guidelines and federal regulations Perform quality review of initially created source documentation, including amendments, to ensure all protocol required procedures are present Provide training and… Click here to view original post
