DUTIES AND RESPONSIBILITIES DESCRIPTION

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 education on SOPs, GCP, and federal regulations as appropriate Prepare for internal and external audits Attend staff meetings Attend site initiation visits as needed Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.