Lanvin Luiz Estacio

Quality Assurance Coordinator @CenExel

Salt Lake City, UT, US

Ensure that high standards of data quality and subject safety are maintained, as well as study protocols, SOPs/SWPs, ICH/GCP, and IRB guidelines, and federal regulations are consistently being followed.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 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 provide a general description of the level and nature of work assigned to this classification and should not be considered all-inclusive.

University of Utah

Master of Healthcare Administration

Brigham Young University - Idaho

Bachelor's degree, Health/Health Care Administration/Management