Silvia Quintero, Cqa Email & Phone Number

United States

Houston, Texas, United States

Houston, Texas Area

• Interview, hire, train and manage Clinical Research Associates at assigned Novum facility.• Conduct annual performance appraisals for direct staff reports.• Provide continual training to Monitoring staff on current regulations and industry trends.• Accompany CRA’s on Site Visits as needed.• Assess workload and assign CRA’s to new projects.• Mentor CRA’s to ensure understanding of Novum SOP’s, work processes and research regulations as needed.• Monitor Study assigned sites for compliance with research regulations and GCP’s.

• Coordinated workflow and logistics of clinical trials. Organize and coordinate the logistics of sending kits and receiving samples for clinical trials to evaluate the effectiveness of diagnostic tests for Alzheimer’s and Parkinson’s disease. • Supervised the laboratory team in processing samples for validation of biomarkers for major devastating diseases. Oversee and assist 8 technicians in the development of the diagnostic test models for breast cancer, Alzheimer’s and Parkinson’s disease. • Managed purchase and maintenance of laboratory instruments and equipment. Researched new equipment. Performed cost/benefit analysis of purchasing new equipment and reagents vs. maintaining existing in order to increase lab capability and productivity without compromising quality and reliability of data. • Performed QA/QC for all processes. Evaluate all documents and processes from sample receipt to project report ensuring GDP, GLP and GCP to warrantee reproducibility and reliability of data. • Assisted and train laboratory technicians. Continuous training of laboratory technicians for new methods, safety, and documentation. Coordinate schedules and assignments as well conducing annual performance evaluations for direct reports.• Designed and implemented an inventory control system. Drafted, designed and implemented Inventory control for managing and tracking samples, chemicals and laboratory supplies from receipt to use or disposal. • Designed and managed a database for receipt, and control of laboratory samples used for clinical trials. Entered and validated data for tracking sample inventory, processing conditions, and related laboratory data.

Oversaw the activities of specialized operational units within the maintenance and operational divisions with responsibility for establishing goals and implementing procedures for different projects, payroll management, hiring, training, budgeting, business relations.

Ms, Biotechnolgy

Advanced Technical Certification, Biotechnology

B.S, Chemistry