Quality Assurance Engineer

Jane Cole

***** ******* **** #*** ****** City, CA 91604 **********@*****.*** Tel: 818-***-****

CAREER SKILLS/KNOWLEDGE

IT Project Management and Methodology

Templates and Reports development

Quality Assurance/Regulatory Compliance

Initiate, Plan, and Execute Control and Closeout Projects

Computer Networking Administration

Project Management

CERTIFICATION

Oracle 9i SQL, Oracle9i PL/SQL, Oracle9iAS Discoverer Reports/End User

Oracle Clinical 4.0.3 (2003), Thesaurus Management system 4.0 (TMS), Advance Validation Procedure, Validation Engineer

Microsoft Certified Professional, Microsoft Certified System Engineer, Microsoft Certified Professional and Internet

WORK EXPERIENCE

Uzuri Lifestyle Magazine Studio City, CA

Regional Manager 12/2007 to Present

Act as day-to- day contact with clients, maintain the accounts of clients, put together advertising campaigns for clients, liaisons between the client requiring the advertising, assist in arranging interviews, and maintaining other forms of public contact; oversee company archives; and respond to requests from clients, manage client communication and delivery details around all campaigns and placing of ads .Liaison between editorial, the advertising sales team, marketing, the printer and outside vendors; determining positioning availability and layout; managing special editions from start to finish; checking ad materials against protocol specs; providing tear sheets; assisting with print billing; addressing any issues and/or special needs with the printer and other ad hoc requests to meet deadlines

Gabod Consulting Group Studio City, CA

Quality Assurance Analyst 02/2010 to 09/2011

Assist with study product shipments, relevant study forms, and study site materials/documentation. Track study activities, including: essential study documents, investigational product shipments, CRA monitoring visits, site monitoring visit reports, and study site correspondence. Ensure guidelines to determine patient status assignment and appropriate setting of care. Interacts with Care Managers to gather data and discuss criteria. Oversee compliance of appropriate vendors in adhering to hospital policy and procedures. Design, implement and ensure compliance with protocols for the optimal, standardized use of selected product, services and processes in collaboration with appropriate department managers. Analyze and modify existing reports as per change requests

California Clinical Trials Glendale, CA

Clinical Research Coordinator 01/2006 to 12/2007

Document, case report forms, medical data review for accuracy. Recruits, scree and enroll participants. Obtain signed participant informed consent. Database monitoring, collection of clinical study data. Ensure accuracy of documentation. Maintain databases, schedule tests and procedures. Develop reports and templates to support business requests. Make modifications to existing systems; revise and maintain existing programs to reflect changes or additions to the company’s lines of business, marketing strategies, vendor enhancements and government regulations. Analyze business functions, evaluate alternatives, make recommendations and create the functional specifications to improve business process. Perform, review and finalize audits of source documents and CRFs at assigned sites. Perform and close audits for IT security controls and compliance corporate policies and requirements.

Medtronic Minimed Northridge, CA

Clinical Research Data Specialist 03/2002 to 11/2005

Protocol development and maintain databases. Collection of clinical research data, create and develop database for study. Evaluate clinical studies, review of charts and case report forms (CRF) and advising the clinical department at assigned site locations on application of industry and internal guidelines, conducted site initiation and training on devices protocol. Gather, validate, maintain, store, retrieve and release data throughout the device life cycle for analysis. Review and resolve data discrepancies with the CRA to determine course of action. Manage, review and edit clinical database to resolve data discrepancies. Close out DCF’s when queries are resolve. Create and maintain clinical database in Oracle Clinical to ensure that the study database is identified and handled correctly. Create a set of annotated CRF’s and copy DCMs, DCIs, DVGs, and Alpha-DVGs from global library, supervised and Trained Clinical Research Analysts. Design CRE using Word and/or Teleform, assist in clinical trials management and associated research activities to ensure ongoing compliance to study protocols, FDA regulations, and IRB requirements Assist in the development and maintenance of various clinical-related databases.

PRN International Tarzana, CA

Senior Quality Assurance Engineer 11/1998 to 03/2002

Oversee and lead infrastructure projects, through start up, project planning, scheduling, monitoring and execution, liaison between the business users and technical teams for IT projects. Script in HTML for web based QA testing design. Develop business and data access cold fusion components. Integrate components into cold fusion pages containing HTML and CFHTML templates developed by design team. Examine inter-company transactions for completeness and accuracy.

EDUCATION

American Intercontinental University, Chicago, Il Master Information Technology, 2003

California State University of Los Angeles, Los Angeles, CA Bachelor of Science Computer Information, 1999

Contact this candidate