Jacqueline Gonzalez
San Diego,CA
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Highly effective at problem solving and decision making. 15 Years of progressive IT experience, with proven ability to respond to a wide range of technical challenges with focused and creative approach.
Overview
27
27
years of professional experience
Work History
CAST Volunteer
City Of Chula Vista
01.2018 - Current
- Provide emotional support, arrange for follow-up services, serve as advocates for local community.
- Assist families with their unique needs in time of trauma.
- On scene liaison for families and Chula Vista Police & Fire.
- Guided troubled individuals to tools and resources necessary for healing.
- Represented City of Chula Vista positively and professionally while providing community with much-needed services.
Office 365 Administrator
Consultant
02.2019 - 05.2019
- Analyzed problematic areas to provide recommendations and solutions to clients based on business impact and value.
- Leveraged built-in and hand-crafted development techniques using native SharePoint/O365 technologies and designed user-friendly end product for custom solutions.
- Provided analytical support and technical advice during conceptualization, development and implementation phases.
Business Systems Analyst
Mitchell International, Inc.
04.2013 - 02.2019
- Office 365/SharePoint Tier III support for 3000+ end users.
- Collected, defined and analyzed business requirements.
- Trained business personnel in use of systems.
- Identified needed business improvements and determined appropriate systems required to implement solutions.
- Coordinated data migration and consolidation efforts.
- Collaborated cross-functionally with product management teams, and other stakeholders.
- Worked with internal and client-focused teams to refine business requirements for software solutions
- Provided support and clarification for both stakeholders and engineering teams during development process.
- Ensured timely delivery high quality solutions through metrics and tracking tools.
Systems Analyst/Administrator I
Amylin Pharmaceuticals, Inc.
01.2007 - 01.2011
- Performed user support, documentation, and training on Enterprise Content Management (ECM) systems.
- Maintained system in compliance with required policies and procedures.
- Tier II and Tier III Software Support for 1000+ internal and external users.
- Mentored, trained, and created training for other IT personnel and system users.
- Interfaced with business to gather requirements for implementations, test scripts, user acceptance, go live, troubleshooting and support including on boarding and training.
- Collaborated with business on design, and governance, as well as development of sites for business functional areas and teams.
- Managed and Supported Content Management Systems, including permissions and group administration, workflow support, user training sessions.
- Assisted business in creating system guidelines, governance and standards.
Clinical Document Specialist
Amylin Pharmaceuticals, Inc.
01.2002 - 01.2006
- Knowledge Manager for Electronic Document Management System (EDMS).
- Authored and trained on Guidelines/SOPs/Work Instructions specific to department processes.
- Prepared digital files, physical documents and work requests in compliance with FDA regulatory requirements.
- Digitally published, compile and QC clinical documents for preparation of Clinical Study Reports in accordance with FDA guidelines for New Drug Applications.
- Liaison between Regulatory Affairs Department, Medical Writing, Clinical Operations and Records Center staff to ensure adherence to guidelines, regulations, internal processes, and achievement of goals.
- Managed projects, tasks, and timelines for Clinical Documents during site start-up, maintenance, and closeout through NDA/eCTD Submission.
- Assisted in development, review and negotiation of Clinical Trial Agreements (CTA), Confidential Disclosure Agreements (CDA), and vendor contracts.
- Monitored expenditures against contracts and budgets.
Clinical Research Coordinator
Synergy Clinical Research
01.2001 - 01.2002
- Coordinated Clinical trials according to GCP and ICH guidelines
- Designed/implemented protocol specific source documentation
- Maintained Case Report Forms and source documentation, per Sponsor's schedule
- Administered protocol specific ratings
- Dispensed medication and tracked drug accountability
- Submitted Serious Adverse Event/Data Clarification Forms in accordance with Sponsor timelines
- Participated in site selection, site initiation, monitoring, and closeout visits.
Regulatory Administrator/Quality Assurance
BMR Healthquest
01.2000 - 01.2001
- Performed internal quality assurance monitoring/auditing at multiple sites.
- Maintained critical documents on all clinical trials conducted.
- Submit clinical trial documents to Ethics Review Boards
- Timely submissions of IND Safety/Adverse Event Reports
- Liaison between Sponsors, Clinical Research Organizations, and Institutional Review Boards.
- Assisted with FDA, Sponsor, and Institutional Review Board audits.
- Assisted Clinical Research Coordinators with monitoring visits
- QA/QC of Case Report Forms.
Project Coordinator
Children's Hospital/SDSU Foundation
01.1997 - 01.2000
- Managed and trained new interviewers.
- Interviewed 200+ families for Longscan/Patterns of Care Project.
- Kept projects on schedule by managing deadlines and adjusting workflows.
- Supervised multiple projects from project start through delivery by prioritizing needs and delegating assignments.
- Organized, sorted, and checked input data against original documents.
- Translated documents from English to Spanish.
Education
Bachelor of Arts - Psychology
San Diego State University
San Diego, CA05.2001
Skills
- Bilingual: Spanish
- Critical Thinking
- Problem Solving
- Collaboration Solutions
- Requirements Gathering
- Effective Communication
- Office 365 Administration
- Site Collection Management
- Analytical and Critical Thinking
- Multitasking Abilities
- Team Collaboration
- MS Office
References
Available Upon Request
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
The best way out is always through.
Robert Frost
Timeline
Office 365 Administrator
Consultant
02.2019 - 05.2019
CAST Volunteer
City Of Chula Vista
01.2018 - Current
Business Systems Analyst
Mitchell International, Inc.
04.2013 - 02.2019
Systems Analyst/Administrator I
Amylin Pharmaceuticals, Inc.
01.2007 - 01.2011
Clinical Document Specialist
Amylin Pharmaceuticals, Inc.
01.2002 - 01.2006
Clinical Research Coordinator
Synergy Clinical Research
01.2001 - 01.2002
Regulatory Administrator/Quality Assurance
BMR Healthquest
01.2000 - 01.2001
Project Coordinator
Children's Hospital/SDSU Foundation
01.1997 - 01.2000
Bachelor of Arts - Psychology
San Diego State University
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