Cassandra Sio Email & Phone Number

Marlborough, Ma, Us

Abbott Park, Illinois, Us

San Diego, California, Us

San Diego, California, Us

Sant Cugat Del Vallès, Barcelona, Es

• Monitor for multiple sites, reviewing CRFs, processing worksheets, logs, and forms • Implemented excel trackers to consolidate information in one centralized location • Works collaboratively with multiple divisions within the same company • Primary contact for procurement. Open POs, reviewing invoices from vendors, submitting Goods Receipt for work completed• Assisted with the build of eDC system, complete UAT and review DMP• Works collaboratively with CDM to ensure queries are closed in a timely manner and that data is cleaned up to meet timelines • Lead, prepare and participate in team meetings and generate meeting minutes• Development of study-specific instruction manuals while creating and shipping investigator site binders for trial sites• Assist with ordering and tracking clinical supplies in preparation of new trials and during the trial• Act as Document Coordinator responsible for creating and maintaining Trial Master Files (TMF), scanning, filing, and retrieving clinical trial documents for/from the TMF/electronic TMF (eTMF)• Manage sample shipment, receipt, handling and storage• Process improvement on a department level and study level to make documents more relevant to studies

Sant Cugat Del Vallès, Barcelona, Es

• Monitor for internal testing sites• Primary contact for procurement. Open POs, reviewing invoices from vendors, submitting Goods Receipt for work completed• Assisted with the build of eDC system, complete UAT and review DMP• Prepare and participate in team meetings and generate meeting minutes• Development of study-specific instruction manuals while creating and shipping investigator site binders for trial sites• Assist with ordering and tracking clinical supplies• Act as Document Coordinator responsible for creating and maintaining Trial Master Files (TMF), scanning, filing, and retrieving clinical trial documents for/from the TMF/electronic TMF (eTMF)• Manage sample shipment, receipt, handling and storage• Improve processes on a department level and study level to make documents more relevant to studies

Ca, 92121, Us

• Prepare and participate in team meetings and generate meeting minutes• Assist with development of study-specific instruction manuals while creating and shipping investigator site binders for trial sites• Assist with ordering and tracking clinical supplies• Assist CRAs with collection, review and tracking of essential documents• Act as Document Coordinator responsible for creating and maintaining Trial Master Files (TMF), scanning, filing, and retrieving clinical trial documents for/from the TMF/electronic TMF (eTMF)• Manage sample shipment, receipt, handling and storage• Maintain sample inventory and tracking through LIMS • Utilize eCDM to track, ship, and receiving samples, as well as conducting double data entry in eCDM prior to locking pages for completion• Improve processes on a department level and study level to make documents more relevant to studies

Ca, 92121, Us

Research and Development of the CE Marked Aptima HBV Quant Assay for the Panther system - Diagnostic Division. Specialization in assay development for the Panther, a fully automated chemistry and immunoassay instrument. Assay development in the Diagnostic Division for HBV detection in blood, serum and plasma. Experience in Assay Integration and Validation and Verification in a GLP and QSR (cGMP) lab environment. • Knowledge and experience of proprietary technologies involving RT-PCR, specifically Transcription Mediated Amplification (TMA) and Hybridization Protection Assay/Dual Kinetic Assays (HPA)• Research and develop a quantitative and qualitative NAT assay (HBV) used in blood screening• Design and execute experiments to complete a segment of overall project • Analyze data and troubleshoot any problematic aspects of the assay.• Test clinical samples for infected viruses such as; HBV using the Panther automated machine. • Write, revise and execute protocols for Assay Integration and V&V submission. • Manage project’s workload, organized small meetings and updates on project progress. Inspect and manage lab safety and inventory supplies. • Present monthly presentations and reports at group meeting. • Experience handling and testing with whole blood samples

Biological Sciences, Human Biology

Certification In Bio-Manufacturing And Quality Control/Research Associate, Biotechnology

Education record

Education record