Karina Lizzi-Ansok, Mph, Mba Email & Phone Number

Ferndale, MI, US

• Develop multi-dimensional strategies for delivering the portfolio at the program and therapeutic area level.
• Influence the program and senior leaders through innovative solutions and study level country/site strategies.
• Synthesize key data and disease/therapy area intelligence for effective trial placement and recruitment strategies.
• Convey complex information to stakeholders and executive audiences in an understandable and actionable manner.
• Lead global/cross functional initiatives to improve operational efficiencies that drive recruitment goals.
• Provides mentorship and guidance to Feasibility Strategy & Analytics Leads.

• Supported and Managed processes relating to Program, Protocol, Country & Site feasibility
• Supported/advised the Site Identification and Site Feasibility Process
• Maintained continuity connecting and documenting changes from Early Estimates, Early Feasibility, Detailed Assumptions, Detailed Feasibility, to Recruitment & Start Up Planning
• In support of Clinical Operations, drove early feasibility (before core protocol elements are available)
• Supported Clinical Operations roles early in the development cycle, providing initial enrollment timelines, High Level Budget (Op Plan), potential Country Footprint, develop key assumptions.
• Supported Clinical Operation roles in Optimizing Operational Protocol Design

United States

• Supported process and departmental innovations, including development of playbook to support streamline of work processes. (Playbook Owner)
• Assisted in training and onboarding of new team members, including recording of lessons to use for new hires.
• Sourced and analyzed data to develop site and patient strategies for proposals and conduct strategic site identification assessments.
• Managed feasibility offerings, including pre-award efforts and post-award Site ID assessments, from the Request for Proposal stage through the end of the site ID process, delivering accurate and robust data-driven.
• Developed and built strong relations with all internal and external customers, ensuring clear communication channels are maintained at all times.

United States

• Sourced and analyzes data to develop site and patient strategies for proposals and conduct strategic site identification assessments.
• Managed feasibility offerings, including pre-award efforts and post-award Site ID assessments, from the Request for Proposal stage through the end of the site ID process, delivering accurate and robust data-driven.
• Developed and built strong relations with all internal and external customers, ensuring clear communication channels are maintained at all times.
• Playbook owner

United States

• Served as functional bidder for multiple service and stand-alone RFPs as appropriate; prepares/oversees preparation of the budget and text for proposals for which feasibility and/or site identification is included.
• Lead cross functional teams to coordinate full feasibility efforts; responsible for final report creation and delivery, as well as presentation to the client in close collaboration with Covance therapeutic experts.
• Conducted data mining of internal and external databases and initiates/oversees the collection of primary data for use in development of robust strategies for clinical trials (country/site mix, site selection.
• Actively participated on cross-functional teams that plan, analyze, and present proposals and bid defenses as part of winning new business and maintaining client base.

United States

• Lead RFP/RFI development processes and timelines to support an efficient, high quality and timely proposal submission and scope change process.
• Managed RFP/RFI proposal submission process and timelines to exceed customer expectations and facilitate an efficient, high quality, and timely submission.
• Developed budgets and texts based on strategic RFP/RFI parameters.
• Reviewed budgets and texts with operational lead assigned to the RFP and prepare/analyze proposed budget metrics.
• Scheduled and participated in strategy calls and budget review calls in accordance with submission timelines.
• Submited proposal package within timelines requested by sponsor.

United States

• Business Development, Proposals
• Supported Business Development efforts to generate annual sales objectives.
• Developed Proposals, time, and budget estimates based on team meetings and discussions.
• Maintained Department tracking, including information about proposal submission timelines, as well as proposal value.
• Served as a Business Development Liaison to other inVentiv Health Clinical departments.
• Supported Client-Service and marketing activities, as requested.

Ann Arbor, MI

• Global Safety and Pharmacovigilance-Sr. Safety Assistant September 2015- May 2016-GSPV Associate June 2016-September 2016
• Composed adverse event narratives and perform a preliminary assessment of event seriousness.
• Triaged cases, generate queries, liaise with medical reviewers, and provide support for PV lead.
• Forwarded safety report documents to clients and other relevant parties.
• Ensured case files are compliant with SOPs.
• Worked with safety databases- ARGUS and ARISg- to submit adverse event reports to regulatory authorities.Silver- Extra Effort Award Recipient

Medical Science Research Building

• Department of Internal Medicine | Division of Gastroenterology
• Wrote and submitted educational and investigator initiated grants; obtained over $60,000 for the Division.
• Conducted administrative and clinical aspects of industry sponsored and investigator initiated clinical research trials
• Recruited eligible study patients, managed study budgets and contracts, drafted IRB applications and informed consent documents
• Interacted with multiple study subjects on a daily basis and monitored: patient conditions, diagnostic labs, and responses to investigational therapies.
• Reviewed medical records for eligibility criteria and obtain informed consent by briefing patients on the study, treatment plan and risks and benefits of the study.

Miami/Fort Lauderdale Area

• Department of Public Health Science | Division of Environmental & Public Health
• Developed R01 proposals for NIAID submission for Dr. John C. Beier’s vector biology team
• Prepared and proof-read team scientific manuscripts on vector biology and ecology
• Compiled data and figures for manuscripts and for scientific presentations
• Translated manuscripts, grant proposals, and accompanying documents into Spanish
• Collaborated with scientists, post-doctoral associates, and graduate students

Miami/Fort Lauderdale Area

• Department of Public Health SciencesThe Role of Culture in Thriving and Risk Behavior in Hispanic Adolescents
• Served as Clinical Supervisor for Dr. Seth Schwartz’s Social Identification study on the acculturation of Hispanic adolescents into American culture
• Reported and resolved all adverse events
• Supervised participants and managed participant reimbursement
• Conducted all relevant communications with Miami-Dade County Public Schools to organize adequate room arrangements for surveying participants
• Tracked and oversaw all data uploads; cleaned and managed data on SPSS

Notre Dame, IN

• Institute for Latino Studies
• Transcribed and translated interviews for Dr. Daniel Groody for his study on migrant movement
• Created presentations on Dr. Groody’s work for academic presentation
• Researched immigration and social service programs
• Assisted the Hispanic Chamber of Commerce on their Landscape Project regarding employee demographic
• Assisted Dr. Irene Park in a project examining discrimination and coping of Mexican American adolescents adjusting to life in the United States

Master Of Business Administration (Mba)

Master Of Public Health (Mph), Epidemiology

Bachelor Of Science (Bs), Science Preprofessional (Pre-Medicine)

Activities and Societies: Study: −Science PreProfessional Major −Italian Minor: Member of Gamma Kappa Alpha, Italian Honor Society.