Ruby Davis Email & Phone Number

Maryland, United States

• Responsible for the planning, execution, and performance of deliverables/timelines/results to meet VA and Sponsor commitments for assigned clinical trial study (Ex: Study start-up/registration, execution and close out).
• Main point of contact for several assigned clinical trials. Primary liaison between sponsor and VA clinical sites.
• Participate in multiple areas of protocol development, and attend scientific steering committee/investigator meeting.
• Review monitoring visit reports and escalates performance issues and training needs to VA management and Sponsor.
• Developed protocol and study-specific trainings to present to VA clinical site.
• Mentored new project managers and provide training on department process, procedures and study-specific trial materials.

Maryland, United States

Delaware, United States

• Contribute to Quality Management System (QMS) by performing process audits, facility audits, SOP audits, CAPA review, client audits, computer system validation (CSV)/equipment qualification audits, new hire compliance.
• Proficient to audit, train and offer guidance to fellow auditors across multiple departments including small and large molecule bioanalysis, translation medicine, and clinical research services.
• Prepare for and assist as support staff during FDA inspections.
• Review and mediate timely closure of audit reports, deviations, and investigations.
• Provide compliance support while auditing multiple aspects of studies including protocols, procedures/ batch records, sample and analyte receipt and usage, data, critical phases, equipment, reports, and personnel.
• Review WinNonlin/SAS verification, clinical pharmacokinetic and clinical study report to support CRS department. Review WinNonlin and pharmacokinetic/toxic kinetic (PK/TK) nonclinical study report to support DMPK.

Delaware, United States

Delaware, United States

Delaware, United States

• Experience working with GLP regulations. Assisted in method development and validation of customized ELISA based assays to support sample analysis for Pharmacokinetics, and Pharmacodynamic studies (preclinical.
• Utilized computerized system (Softmax Pro, and Watson LIMS) to expedite data tables. Additional duties include report writing for validation/sample analysis studies and purchasing of general laboratory supplies for the.
• Experience working laboratory equipment including: IMMULITE clinical analyzer.

Philadelphia, Pennsylvania, United States

• Experience working with GLP regulations. Performed ELISA based assays to support sample analysis for Pharmacokinetic Phase III studies.
• Utilized computerized system to expedite reports and maintained proper documentations (binders/ laboratory notebooks) for each trial.

Delaware, United States

• Assisted customers in troubleshooting and offered technical support for the remediation/water quality immunoassay test kits.
• Performed onsite or phone training for new users to ensure proper knowledge of operating procedure. Maintained existing client database, and placed orders to replenish customer's inventory supplies.

Delaware, United States

• Tested medical diagnostic kits, monoclonal, and polyclonal antibodies. Experience performing customized ELISA, SDS page, western blot, spectrophotometric assays, immunoelectrophoresis (IEP), and radial immunodiffusion.
• Reviewed production lot records, physical inspection of products, and creating Certificates of Analysis. Member of Internal Quality Assurance Audit Team, experience with quality system implementation (ISO 9001, 21 CFR.
• Experience working with laboratory equipment including Cobas Fara, Beckman Array, Amersham Phastgel System.

Bachelor'S Degree, Molecular Biology

Certificate Clinical Project Management Fundamental

Certification Clinical Trial Management