Maria M. Poulin
Milford,OH
Summary
Accomplished, Certified Clinical Research Professional (CCRP) with 15+ years of operational and leadership experience in clinical research, pre and post award financial administration, coverage analysis, study start-up, data management and regulatory compliance. Proven track record of working with high-performing teams at major academic institutions. Skilled in Medicare coverage rules, CTMS (OnCore) utilization, budget development and negotiations, and cross-functional stakeholder management. Adept at driving operational efficiencies, having recovered over $400K in unbilled research revenue and standardized institutional pricing structures.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Clinical Research Coverage Analysis Team Lead
University of Washington Clinical Trials Office
Seattle, Washington
07.2023 - 07.2026
- Coverage Analysis Team Lead
- Served as the primary point of contact for coverage queries from Coverage Analysts and study teams, systematically investigating issues and escalating to the Manager or Assistant Director of Finance when necessary.
- Monitored individual Coverage Analyst workloads by tracking active study volume, protocol complexity, and milestone timelines to proactively identify potential delays and balance team assignments.
- Evaluated incoming internal and outsourced (Advarra) submissions for coverage analysis to strategically assign protocols based on complexity, analyst expertise, and workload metrics to maintain operational efficiency.
- Participated in the interview process for new Coverage Analysts and participated in onboarding by providing incoming staff an overview of processes and systems.
- Collaborated on the refinement of standardized procedures and tools to enhance accuracy and consistency across clinical research coverage analyses.
- Contribute to the development of internal Team metrics for internal use.
- Maintained active delivery of core foundational responsibilities in the Clinical Research Budget Analyst role, as detailed below.
- Coverage Analyst / Budget Analyst
Clinical Research Budget Analyst
Actalent Science & Engineering
05.2022 - 07.2023
- Perform coverage analysis and established billing grids in CTMS (OnCore), as well as reviewing and validating coverage analysis performed by a third party vendor (Advarra). Interpret and apply Medicare coverage rules and designating study items and services as non-covered research-only or covered routine.
- Advise investigators and study teams on applicable regulatory requirements pertaining to coverage analysis decisions.
- Communicated with study teams via phone and MS Teams to discuss and promote a better understanding of protocol nuances that effect coverage analysis, as well as explain process requirements.
- Perform compliance review of all documents related to research study funding, including the protocol, research study budget, contractual terms, informed consent and other supporting documentation to ensure congruency, completeness and appropriate language, specifically for cost and subject injury sections. Ensure alignment of these documents with the billing grid and federal regulations.
- Track projects through multiple milestone points in the CTO database. Manage tickets and communications regarding work performed in compliance with office policies, procedures, and standards.
- Provide assistance in completion of special projects to ensure deadlines are met.
- Contractor: Budget Analyst @ University of Washington
- November 2020 – June 2021
- October 2021 – April 2022
Contract Specialist
Medpace
Cincinnati, Ohio
06.2020 - 10.2020
- Provided site and vendor contracting support services to Contract Attorneys and Clinical staff.
- Managed, tracked, and reported on status of documents relating to study agreements with clinical research sites globally, to ensure contracts are electronically stored, indexed and, whenever possible, searchable.
- Served as the primary liaison for assigned projects, managing communications between internal teams and external stakeholders managing communications between internal teams and external stakeholders, communicating negotiation parameters and requests, and attending/organizing meetings between stakeholders, as needed.
- Prepared and checked original study site and vendor contracts, and gather information on negotiation requests and forward any requests which require legal review by the Contracts Attorney.
Senior Coverage Analyst – Office of Clinical Research
Indiana University School of Medicine
Indianapolis, Indiana
11.2017 - 06.2020
- Played a pivotal role in the foundational build-out of the Coverage Analysis Team, developing core onboarding materials, performance metrics, and strategic planning.
- Directed and audited the outputs of five Junior Coverage Analysts, providing senior-level quality reviews of billing designations, justifications, and ICF alignments.
- Developed and systematically updated the University Standard Pricing schedule to ensure accurate institutional cost recovery.
- Supported the implementation and management of a new clinical research billing process to individual departments resented on topics related to clinical research finance/budgeting and research billing compliance for various coordinator education series and departments.
- Served as a University Subject Matter Expert for industry-sponsored clinical trials budget creation and negotiation and entry and maintenance of financials in OnCore CTMS for budgeting, invoicing, and reconciliation of accounts.
- Present on topics related to clinical research finance/budgeting and research billing compliance for various coordinator education series and departments.
- Delivered educational presentations on clinical research budget development and negotiations for study coordinators and clinical staff (2014 to 2020)
Clinical Research Fiscal Compliance Officer
Neuroscience Clinical Research Services
07.2012 - 10.2017
- Reviewed new clinical research protocols to develop and negotiate Industry and foundation funded clinical research trial budgets. Reviewed payment terms and conduct cursory review of contracts for multiple program areas within the Neurosciences.
- Collaborated with study teams to determine feasibility of study by evaluating protocol, study design, and risk to subject population. Determine staff and facility availability; assess study population/availability; and gain understanding of protocol in order to create accurate budgets.
- Managed financial administration both pre and post award for all sponsored clinical research accounts within Neuroscience. Responsible for set- up, management, accountability, and reporting of expenditures and income for an average of $35 million in contracts across over 80+ trials.
- Managed the end-to-end sponsor invoicing lifecycle for clinical research agreements, ensuring the accurate processing and reconciliation of all incoming trial revenue.
- Established, implemented, and maintained tracking systems and tools to support the conduct of clinical trials pre and post award, including a standardized Neuroscience pricing and a department-level system for invoicing and tracking of trial income and other metrics.
- Act as the liaison between Coordinators and IU Health Revenue Cycle in resolving Billing Compliance issues where research subjects had been charged for services in error.
- Implemented OnCore (CTMS) for Neuroscience, as well as supported over all implementation of OnCore at an Institutional level.
- Collaborate with Neuroscience Administration in ensuring research activities are conducted in an efficient, cost effective manner.
- Served on Financial & Billing Compliance Panel for University level Coordinator training.
- Served as Subject Matter Expert for Industry Sponsored Clinical Trials Budget Creation and Negotiation, as well as implementation of OnCore/CTMS financial at a University level.
- Initiated and assisted in the development of Indiana University Standard Pricing for use within budget development and negotiation of all IUSM Industry Sponsor Studies.
- Served as unit representative for University committees, work groups, and task forces; including: University CTMS/EDC Initiative, Research Support Group, IRB Services Group, multiple OnCore/CTMS Committees and Work Groups, Best Practices for Clinical Trials Budgeting – Process Mapping, Rapid Improvement Exercise for development of Coverage Analysis Team and better Clinical Research Billing Processes, OCR Extended Lead Team, and Financial & Budgeting Sub-group.
Clinical Research Manager
Alzheimer's Research in the Department of Neurology
07.2010 - 06.2012
- Directed administrative and clinical operations for the Alzheimer's Research Program, providing personnel supervision to coordination staff.
- Recovered over $400,000 in historic unbilled revenue by systematically auditing 25 neglected study accounts. Negotiated with Sponsor to allow invoicing past contractual time limits.
- Formulated strategic operational assessments for Neurology executive leadership to restructure research workflows for superior fiscal sustainability.
- Facilitated critical communications with study sponsors regarding clinical trial milestones, fiscal adjustments, patient-related issues, and regulatory procedural requirements.
Clinical Research Specialist
Indiana University Simon Cancer Center
02.2008 - 07.2010
- Work with Sponsors and IUSCC teams in the implementation and coordination of Clinical Research Trials.
- Coordinated end-to-end initiation, monitoring, data management, and regulatory workflows for high-complexity oncology clinical trials in compliance with Standard Operating Procedures and Good Clinical Practices.
Senior Scientific Communication Editorial Assistant
Eli Lilly and Company
Indianapolis, Indiana
05.2007 - 02.2008
- Managed documentation workflows, source data validation, and editorial compliance for IND applications, Investigator Brochures (IB), protocols, and formal FDA response documents.
Contractor: Medical Assistant – Slide Editor
Volt Scientific @ Eli Lilly and Company – USMD
Indianapolis, Indiana
04.2006 - 05.2007
- Managing the design, technical layout, and multi-software integration of clinical content.
- Oversee quality control pipelines and vendor budgets for the US Medical Division, validating source data consistency across slide kits and generating executive metrics reports.
Education
Master of Science - Psychology and Certificate in Management
Manhattanville University
Bachelor of Arts - Psychology and Certificate in Management
Manhattanville University
Master of Arts Program - Applied Counseling Program
Long Island University
Skills
- Coverage Analysis
- Clinical research budget development
- Invoice processing for clinical trials
- OnCore
- MS Excel
- Visio
- Effective communication
- Problem solving
- Customer focus
Affiliations
- SoCRA: Certified Clinical Research Professional (CCRP).
- Member - Model Agreements and Guidelines International (MAGI)
Certification
Ø SoCRA: Certified Clinical Research Professional (CCRP).
Ø Member - Model Agreements and Guidelines International (MAGI)
Timeline
Clinical Research Coverage Analysis Team Lead
University of Washington Clinical Trials Office
07.2023 - 07.2026
Clinical Research Budget Analyst
Actalent Science & Engineering
05.2022 - 07.2023
Contract Specialist
Medpace
06.2020 - 10.2020
Senior Coverage Analyst – Office of Clinical Research
Indiana University School of Medicine
11.2017 - 06.2020
Clinical Research Fiscal Compliance Officer
Neuroscience Clinical Research Services
07.2012 - 10.2017
Clinical Research Manager
Alzheimer's Research in the Department of Neurology
07.2010 - 06.2012
Clinical Research Specialist
Indiana University Simon Cancer Center
02.2008 - 07.2010
Senior Scientific Communication Editorial Assistant
Eli Lilly and Company
05.2007 - 02.2008
Contractor: Medical Assistant – Slide Editor
Volt Scientific @ Eli Lilly and Company – USMD
04.2006 - 05.2007
Master of Science - Psychology and Certificate in Management
Manhattanville University
Bachelor of Arts - Psychology and Certificate in Management
Manhattanville University
Master of Arts Program - Applied Counseling Program
Long Island University