David Hernandez Email & Phone Number

Raleigh, NC, US

Durham, North Carolina, United States

• Troubleshoot instrument and process breakdowns in a timely manner to ensure high-throughput operations of the clinical laboratory.
• Improve automated processes through root cause analysis of robotic equipment malfunctions and fine-tuning of teaching processes.
• Maintain the lifecycle of laboratory assets through the CMMS by performing preventative maintenance, executing work orders for repairs, and documenting all asset-related events while following GDP.
• Qualify and onboard automated equipment per IOPQ protocols, ensuring FDA/GMP compliance and supporting laboratory growth.
• Communicate equipment updates, breakdowns, and needs across clinical and engineering teams to ensure smooth operations and process adjustments and escalating major breakdowns to vendor FSEs and other appropriate.

• Coordinated subject recruitment and specimen collection for oncology and COVID-19 studies, leveraging EMR system to identify eligible participants.
• Ensured compliance with HIPAA, IRB, and FDA regulations, while maintaining ethical subject interactions.
• Oversaw data collection and entry into case report forms (CRFs) to ensure accurate, complete study data.
• Drove collaboration with Ochsner Research teams and external CROs, ensuring smooth project execution.
• Managed data traceability and invoice processing using LIMS, EMR, and CTMS.
• Contributed to refining SOPs to optimize subject engagement, specimen processing, and data quality.

New Orleans, Louisiana, United States

• Processed, stored, and shipped biological samples for various clinical trials and research projects across Ochsner Research’s subdepartments (oncology, cardiology, transplant hepatology, infectious diseases).
• Ensured proper documentation, labeling, quality control, and operation of lab equipment, including centrifuges, freezers, and cryopreservation tanks.
• Contributed to sponsor audits and monitoring visits by providing equipment certifications and conducting lab tours to ensure site compliance.
• Monitored supply levels of consumables and collaborated with BCRL staff and CRCs to troubleshoot sample collection and processing issues.
• Coordinated with BCRL staff to fulfill sample requests for ongoing research projects.
• Assisted in the development and implementation of SOPs for efficient, accurate sample processing, storage, and transportation.