Scott Smith, MBA, CCRP
Research Operations Consultant
Managing Principal
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About
I am an experienced clinical research professional and business owner with more than a decade of work across research site and industry settings. My expertise centers on budgeting, contract negotiation, and operational strategy helping clients identify hidden risks, strengthen financial integrity, and improve study feasibility. I founded Szumcon Research Strategies to provide independent, client-facing support that combines strategic insight with practical, hands-on experience, delivering structured, reliable solutions for complex needs in clinical research.
Professional Experience
Managing Principal & Consultant
June 2023 - Present
Research Project Manager
May 2023 - June 2025
Clinical Trial Budget Analyst
March 2021 - April 2023
Clinical Trial Specialist
June 2017 - February 2021
Trial Master File Professional
May 2015 - May 2017
Deliver independent, client-facing support through Smith Research Strategies - a Division of Szumcon LLC, specializing in budgeting and contract negotiation for clinical research. Partner with client organizations, agencies, and institutions to develop, analyze, and negotiate site and vendor budgets and payment terms aligned with fair-market value and client policies. Identify hidden risks and unfavorable terms within contracts to protect site interests, strengthen financial integrity, and ensure feasibility across research programs.
Served as an internal consultant supporting strategic planning, cross-functional coordination, and infrastructure design across multiple divisions of the Research Administration. Created policies, SOPs, and workflow tools to close institutional gaps and align day-to-day execution with long-term goals. Emphasized consistency in documentation to promote audit readiness and internal cohesion. Delivered structure in areas lacking precedent, ensuring each system is grounded in purpose and scaled with intention.
Specialized in developing and negotiating clinical trial budgets, integrating coverage analyses (CVA) with institutional standards and sponsor expectations. Forecasted long-range study costs, supported contract execution, and built scalable financial tools for investigator-initiated and industry-sponsored trials. Partnered with investigators and administrators to balance feasibility with compliance, strengthening fiscal oversight across therapeutic areas.
Provided site monitoring and operational support for multi-center trials from feasibility through study conduct, including site activation, IRB submissions, and regulatory documentation. Collaborated with sponsor and site stakeholders to align readiness activities, maintain compliance, and ensure trial continuity. Supported monitoring and data review processes to uphold protocol adherence and efficient study delivery.
Managed trial master file (TMF) systems and document workflows to maintain consistency, accuracy, and regulatory compliance. Specialized in aligning institutional and sponsor practices with the TMF Reference Model, improving usability and audit readiness. Supported cross-functional teams with documentation standardization, remediation, and inspection preparation across multiple studies.
Education
Master of Business Administration
MidAmerica Nazarene University - Olathe, Kansas
Graduated: 2018
Bachelor of Arts in Philosophy & Political Science
Rockhurst University - Kansas City, Missouri
Graduated: 2014
Certifications
Certified Clinical Research Professional (CCRP)
Society of Clinical Research Associates (Expires: 2028)
micro.P3.express Practitioner (µP3P)
OMIMO/certN (Completed: 2025)
P3.express Practitioner (P3P)
OMIMO/certN (Completed: 2023)
