• Create and maintain a vendor database to track which franchise/study and associated services are contracted to key and preferred vendors • Develop, maintain, and/or update tools to aid Functional Group representatives in proactively managing their respective contracted vendors • Ensure study team compliance with Vendor Oversight and other internal SOPs • Work with internal and external stakeholders to identify key performance indicators (KPIs) in developing vendor metrics. Ensure periodic evaluation of these metrics to assess trends related to quality and compliance of vendor’s contracted deliverables and issues• Conduct and/or Review Internal and Vendor Audits as necessary to ensure compliance with Oversight Agreements, KPIs, and ICH-GCP Requirements• Support staff in Regulatory Inspections (EMA/FDA)

Prepare and finalize project plans for global projects (timelines, contingency and communication plans). Identify, acquire and assure proper training of appropriate project resources. Establish and maintain team communication and documentation via internal and external operations meetings with all levels of management. Prepare and participate in project kick-off meetings with internal CRO and sponsor teams. Track and report accurate patient metrics throughout the life of the trial. Coordinate clinical, data management, regulatory and medical project team activities within PAREXEL and act as liaison to sponsor counterparts. Track budget of project finances both internally and with sponsors. Plan and maintain study timelines and milestones, while proactively identifying potential risks and outcomes to timelines during all phases of study conduct. Participate in proposal development teams and attend bid defense meetings with potential clients.

Provide extended support to Project and Functional Leaders during study initiation, maintenance, and close-out phases. Develop and maintain study-specific planning tools including Central Files Maintenance Plan, Project Plan, Recruitment Plan, Communication Plan, SOP Listing, Risk Management and Analysis, and Training Plan. Directly manage client requests including Central Files transition activities, Investigator Meeting preparations, maintaining Database Lock timelines. Host client operations teleconferences and face-to-face audits meetings. Provide live study-specific training on internal study processes and documents. Initiate and manage large-scale tasks including migration of legacy Central Files backlog to PMED and clinical site assessments. Complete investigator and vendor payments in a timely manner. Act as Global Project Specialist for a large-scale legacy program of nine protocols. Mentor new team members in the Project Planning and Support group.

Responsibilities include the coordination and conduct of in-house monitoring activities, review and tracking of regulatory documents, and database setup and maintenance for several studies concurrently. Collect and maintain master site files, record meeting minutes for study team meetings, and generate weekly and monthly reports for sponsor and team members. Support Clinical Research Associates and site investigators to ensure adherence to Good Clinical Practices (GCP) and FDA regulations.

Responsible for leading twice-weekly study sessions for graduate students. Provided individual tutoring and troubleshooting in advanced mathematics and statistics subjects. Assisted students with data set coding in statistical software packages for final research projects

Responsible for performing full analysis of San Diego County Mortality data, including calculations of Years of Potential Life Lost (YPLL) statistics for varying age groups. Managed data and wrote code in varying statistical software packages such as STATA, SAS, SPSS, Microsoft Excel and Microsoft Access to analyze sensitive approximately 20,000 observations and 20 variables. Generated summary report.

• Assisted at information desk, directing patients and visitors to appropriate locations on Kaiser campus.• Developed protocols for daily volunteer activities.• Escorted patients to and from appointments and visits and assisted with patient discharge.• Delivered gifts and other goods to patient rooms.• Answered telephones and responded to inquiries into patient and hospital information.• Trained new volunteers.

Directly assisted the president and C.E.O. with daily management and maintenance of company resources. Performed customer service tasks including responding to inquiries via e-mail and telephone, maintaining databases of current and potential clients, and sales. Developed document templates such as laboratory/business protocols. Performed human resources tasks such as employee interviewing, development of weekly work schedules, development of weekly and quarterly goals for employees, and payroll. Performed regular checks on office and laboratory equipment and protocols to ensure safety maintenance. Performed extensive promotional marketing of company products to regional businesses through email, phone call, and face-to-face interaction with company managers and C.E.O.s. Assisted with planning and organization of antibody research project supported by NIH grant.