Planning and execution of GCP investigator site and vendor/supplier audits. Review documentation and electronic system assessment of clinical trial data and reported outcomes. Versed in North America (FDA) and Global Studies (ICH) guidelines.• Performed GCP quality assurance audits at site locations and labs ensuring ICH GCP, local regulations, and Sponsor protocol and SOPs were adhered to• Provided oversight, support, and collaboration to CRO and Sponsor to address audit findings • Activities included reviews for the routine site audits, mock and for-cause FDA inspections, as well as Sponsor and vendor audits

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As an Associate Director of Clinical Operations, the role was responsible for initiating and leading an early-stage clinical device trial, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives• Accountable for delivery of assigned clinical program budget, timelines, and resource management with a focus on quality• Developed operational strategy and clinical operations plans• Partnered and collaborated with cross-functional stakeholders such as the Project Leader, Clinical Lead, and other relevant stakeholders both within and external to IQVIA• Supported the oversight and management of study vendors and required deliverables• Reviewed and provided clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical operations manual, manual of procedures, and IRB documents • Represented Clinical Operations on cross-functional project teams and vendor/operational meetings and ensured compliance with operational standards and procedures• Developed and managed study-related budget and invoice tracking, in collaboration with finance• Communicated study status, cost, and issues to ensure timely decision-making by senior management

This role of an Auditor entailed planning and execution of Good Clinical Practice audits. Reviewed documentation and electronic system assessment of clinical trial data and reported outcomes.• Performed GCP quality assurance audits at site locations and labs ensuring ICH GCP, local regulations, and Sponsor protocol and SOPs were adhered to• Provided oversight, support, and collaboration to CRO and Sponsor to address audit findings • Activities included reviews for the routine site audits, mock and for-cause FDA inspections, as well as Sponsor and vendor audits

This role involved both planning and managing all aspects of the studies from start-up to close-out to ensure timely delivery with the highest possible quality. In addition, the role required managing the study team, study budgets, and ensuring customer satisfaction.• Managed clinical team and investigators to ensure high-quality study deliverables• First point of contact for sponsors and CRO to ensure projects proceed on time• Communicate with internal and external customers as well as third party vendors• Involvement in identifying, assessing, and contracting suppliers of Central Pharmacy and regional laboratory services

The Associate Director was responsible for the management and oversight of a portfolio of more than 300 active clinical trials. Provided leadership and regulatory structure to the entire team members to execute pediatric and adult cancer trials.• Managed the study start-up in collaboration with the Office of Contracts/Budgets and local IRB • Implemented quality initiatives, providing input to clinical systems, audit planning, and inspection readiness initiatives for adult and pediatric oncology programs• Monitored clinical research monitor visit reports to ensure proper review, management, resolution, and escalation• Responsible for program timelines, budget, and quality deliverables; identification of program risks and issues with escalation to senior leadership and C-Suite• Managed staff site assignments and schedules, documented performance improvement and hiring• Reengineered billing process to realize increased revenue and streamline the timely filing process

This role provided research consulting services to several clinical programs in the State of Missouri. Conducted gap analysis evaluations of business operations to enhance start-up processes, regulatory compliance, implement quality management system processes, and computer technology integration.• Planned and led the execution of the day-to-day activities for the conduct of clinical studies and communicated consistently with the clinical team providing project objectives, expectations, and status updates• Developed risk mitigation strategies, and associated action plans to issue resolutions for sponsor and FDA site inspections ensuring ICH-GCP, federal, and state regulatory compliance• Implemented a clinical trial management system to ensure accurate metrics, reporting, and data tracking • Monitored the quality of clinical deliverables and addressed quality issues with the appropriate team member

This role was responsible for the development and successful execution of a cohesive clinical research program in a rural hospital system.• Assured compliance with CFR, state regulations, ICH-GCP guidelines, and site SOPs • Drove clinical operations, inclusive of program planning, project management, operational budget, efficient use of resources, appropriate inventory, and personnel management• Authored research sections of ACOS and Stemi2 applications; received honors

As a member of an audit team this role assisted in preparation for filing with the FDA.• Conducted a GCP review for a pharmaceutical sponsor in preparation for their FDA filing.• Collaborated with regulatory, monitors, and project management to rectify files and documentation

This role spearheaded clinical trial management activities for strategic input, oversight, and expertise to ensure clinical operations were executed on time, within budget, and with dedicated attention to subject safety.• Supervised 54 staff in a cross-functional team to ensure quality assurance measures and risk mitigation efforts maintained• Negotiated grants, contracts, and budgets to support an annual $30 million operational portfolio• Designed a robust education program to train research personnel about the clinical research process, ethics, and process