Merck

Associate Principal Scientist, Global Trial Optimization

Senior Scientist

Syneos Health

*Collaborate and align with clinical trial team members and departmental leadership to ensure accurate, comprehensive, and high-quality  deliverables that drive towards goals.
*Utilize a global perspective and understanding of early trial design and country capabilities to propose countries for feasibility validation, to develop feasibility materials, and to guide feasibility planning and execution.
—In conjunction with clinical and study management teams, educate country operations teams on trial design and challenges, as well as validation materials,  procedures, and considerations
—Utilize validation data to project trial enrollment periods and determine the number of sites needed to support the trial enrollment target
—Analyze and review validation results with key stakeholders to determine if sufficient trial support is available and recommend countries for  participation in the trial based on site and country-level validation feedback
*Assess trial design in consideration of challenges and opportunities for recruitment, retention, and study execution. Utilize identified challenges and opportunities to establish recruitment and retention plans.
—Communicate budget needs for recruitment and retention plans
—Determine if and which types of vendor support are needed; organize trial and program-level implementation with applicable vendors; review vendor performance throughout the trial(s) and program
—Educate trial-site investigators and staff, as well as country operations teams on supporting features of recruitment & retention plans and application
*Track trial enrollment performance against enrollment projections and analyze protocol amendments to consider if additional actions are needed.

Project Manager II, Senior Global Trial Optimization Specialist dedicated to Merck

Project Manager I, Global Trial Optimization Specialist dedicated to Merck

The University of Kansas Cancer Center

*Manage and lead a team of clinical research coordinators to produce high quality trial participant care and data
—-Onboard and successfully train new employees
—-Promote learning & development
—-Allocate projects
—-Create and maintain an environment conducive to strong communication, as to ensure day-to-day challenges and concerns are addressed promptly

*Conduct monthly Disease Working Group meetings to discuss opportunities for new trials with physicians, and troubleshoot any issues with ongoing trials

*Effectively engage various project teams to align goals and efficiently operationalize trials from start-up to close-out
—-Assemble protocol feasibility for multiple review committees
—-Orchestrate numerous milestones, including study activation, with regulatory, finance, legal, investigational pharmacy, and other teams, as applicable

*Educate trial sponsors on site practices and policies to ensure successful collaboration

*Develop and maintain relationships with physicians and treatment teams for continued understanding of evolving needs within the clinical trial portfolio and patient care landscape, and subsequently correlate those needs into updated processes

*Conceptualize and implement new strategies for effective departmental growth, both individually and as part of a team

*Network and diversify my knowledge at numerous seminars, such as Fred Pryor and ASH (American Society of Hematology) Conference 2019

*Stay up-to-date on process and policy changes, to ensure compliance for myself and my team

Associate Project Director - Hematology

*Analyze and implement numerous clinical trial protocols, within multiple hematologic oncology disease and treatment indications, including the following:
—-Attend SIVs and lead site trial kick-off meetings with functional groups
—-Patient education and consent, subject pre-screening and screening, trial subject enrollment, subject assessment completion per protocol, deviation and SAE reporting
—-Collaborate with various patient care teams to promote high quality patient care and trial data
—-Utilize multiple EDC, IWRS, and central lab portal systems such as Medidata Rave, Bracket, and Covance

*Adhere to local regulatory, ICH-GCP, QA, IRB, and HIPAA requirements and guidelines

*Attend various Investigator Meetings and educational conferences, such as the 2018 SOCRA conference

*Successfully train new employees:  clinical data coordinators and clinical research coordinators

Hematologic Oncology Certified Clinical Research Coordinator

*Collaborate within project team and with numerous sites to track investigator recruitment and start-up/ongoing trial activities
—-Essential document collection, review, and tracking with subsequent Trial Master File Management, in compliance with local regulatory requirements and ICH-GCP guidelines
—-Quality Informed Consent Form review

*Support site staff with protocol questions and local IRB/IEC submissions

In-House Clinical Research Associate

Konza Lab Connection, Inc.

Toxicology Coordinator

Kansas State University College of Veterinary Medicine

*Abide by lab safety and sanitization protocols and procedures

*Learn, enact, and write SOPs for new techniques, as needed by graduate student research on antibiotic resistance
—-Qualitative and Quantitative PCR
—-Microcapillary and Gel Electrophoresis
—-Minimum Inhibitory Concentration Assays
—-Southern Blot Procedure

*Successfully train new employees

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