Experience

Public Health Institute

• United States
• Non-profit Organizations
• 500 - 600 Employee

• Regulatory Project Manager

  • Jun 2018 - Present

  • Audit and review regulatory documents per CTMB, OHRP, NCI, FDA, HIPAA and GCP policies and standards • Review CIRB protocols, submissions, amendments and continuing reviews • Monitor clinical trials through data validation and data management via iMedidata RAVE, eRDES, etc. • Serve as the primary point of contact for quality management/operational processes questions • Report Serious Adverse Events (SAE) per protocol requirements, within NCI guidance to evaluate ATMP causalities such as IND/IDEs • Submit Unanticipated Problem Safety Reports to the FDA • Manage the Corrective and Preventative Action plans (CAPA) program for deviation management • Administer standard operating policies relating to Quality Assurance and Audit • Collaborate with functional leadership teams to develop an implementation strategy for a continuous improvement culture and management system • Generate and interpret data submissions to support effective planning, risk management, quality improvement processes • Conduct staff onboarding, yearly continuing education seminars on Quality Assurance and Regulatory Affairs, and deliver quality training to the team • Create, maintain, and deliver training to support the advancement of operational excellence Show less



Doheny Eye Institute

• United States
• Non-profit Organizations
• 100 - 200 Employee

• Study Coordinator II, Lead

  • Jun 2016 - Jun 2018

  • Supervised Study Coordinator team to meet various clinical trial deadlines. Trained and mentored team members • Assisted with hiring, disciplinary actions, and yearly reviews of the department • Served as a liaison between sponsors and inter/national clinical centers • Reviewed study compliance against protocol, operating procedures, and regulatory guidelines • Complied with FDA, OHRP, HIPAA, federal regulations/ICH guidelines, GCPs and SOPs • Improved processes to increase efficiency of operational procedures, reporting methods, and protocols • Contributed to quality improvement efforts by partaking in stakeholder meetings with the focus of negotiating time commitments and resources within the department • Maintained accurate tracking of source documents and evaluated quantitative data • Participated in routine sponsor audits of process, quality and federal compliance • Prepared and submitted regulatory packages to IRB with amendments and annual reporting • Coordinated and led the initiation of new protocols, training materials, and kick off meetings Show less



American Red Cross

• United States
• Non-profit Organizations
• 700 & Above Employee

• Phlebotomy Technician

  • Jan 2014 - Oct 2015

  • Trained and supervised incoming staff on QC procedures, and skills necessary • Interacted with donors, doctors and vendors at all levels of operations • Met the quality production and distribution goals established • Performed quality control on products and equipment to meet regulatory requirements • Maintained and reviewed electronic records to assure accurate record keeping • Ensured products are suitable for distribution are managed appropriately • Actively participated in problem solving on cross-functional teams • Performed reviews of regulated documents, logs and forms as directed Show less



California State University, Northridge

• United States
• Higher Education
• 700 & Above Employee

• Team Research Leader

  • Jan 2013 - Dec 2014

  • Aided with the development and execution of clinical cancer research studies • Worked under specific instructions to run routine tests, experiments, and procedures • Ensured compliance with all established policies and procedures • Provided input with Study Design and Study Protocols using provided feedback • Assisted in the setup, operation, and maintenance of all research equipment and instruments • Provided training of personnel • Analyzed trial reports • Aided with the development and execution of clinical cancer research studies • Worked under specific instructions to run routine tests, experiments, and procedures • Ensured compliance with all established policies and procedures • Provided input with Study Design and Study Protocols using provided feedback • Assisted in the setup, operation, and maintenance of all research equipment and instruments • Provided training of personnel • Analyzed trial reports



Comprehensive Community Health Centers

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Administrative Assistant

  • Sep 2007 - Jan 2012

  • Reconciled daily cash and credit operations while maintain budget analysis • Assisted in billing: including verification of invoices, and payment options • Maintained and organized an electronic database of all fiscal transactions • Updated daily management reports for resource allocation • Worked with internal and external vendors for maximized efficiency • Monitored delinquent accounts, and unpaid balances • Participated in a strategic planning committee devoted to improving procedures Show less