Catherine Gregor

Experience

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  North Chicago Veterans Administration Medical Center (NCHVAMC)

  Aug 2005 - Aug 2008

  Senior Clinical Research Administrator

  Managed clinical research and grant activities within a federal healthcare system.

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  Rosalind Franklin University

  Oct 2005 - Aug 2008

  Oversaw the development and implementation of a robust clinical research center. Managed the contract and regulatory process for a myriad of protocols; including wound care, infectious disease, and vascular studies. Facilitated site inspections and patient enrollment activities while maintaining regulatory oversight of 3 satellite locations. Monitored grant application process and funds procurement for an academic research unit under the direction of the Dean of Research.

  • Clinical Research Manager

    Mar 2006 - Aug 2008

  • Senior Clinical Research Administrator

    Oct 2005 - Mar 2006
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  Broadlawns Medical Center

  Aug 2008 - Aug 2009

  Clinical Research Manager

  Managed all clinical project planning of investigator-initiated and industry-sponsored research programs, including negotiation of resources, timelines, trial budgets and clinical study agreements with industry sponsors. Developed source documents, informed consents, product accountability and recruitment materials in compliance with the study protocol. Oversaw the clinical training activities and development of ancillary staff.

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  Compass Point Research

  May 2010 - Jul 2019

  Contracted to provide guidance on budget and contract negotiation processes for multiple clients while advising on regulatory and compliance related issues including, but not limited to, CMS billing requirements, Medicare Coverage Analysis, and physician reimbursement models. Actively contributed to the strategic development of company operations in support of market share growth. Responsible for demonstrating strong project planning, strategy, leadership, negotiation and presentation skills as well as an ability to contribute creatively and practically to resolve problems and capitalize on opportunities. Worked collectively with leaders throughout the organization to identify opportunities for operational improvement and revenue enhancement. Established and maintained relationships with sponsoring companies, investigators and institutional research units to optimize the performance of clinical research activities while managing the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas.

  • Contract and Budget Consultant

    Jan 2014 - Jul 2019

  • Director, Operations

    Apr 2013 - Jan 2014

  • Regional Operations Manager

    May 2010 - Apr 2013
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  Vanderbilt University Medical Center

  Jan 2014 - Sept 2015

  Project Manager III, Vanderbilt Institute for Clinical and Translational Research (VICTR)

  Research and regulatory consultant responsible for addressing complex issues involving federal and industry-funded initiatives. Worked in conjunction with teams to identify solutions and develop improvement processes by serving as a central resource on operational goals, business strategies, ethical considerations, regulatory mandates, and institutional policies related to human research protections. Also was responsible for collaborating with internal and external customers to develop and evaluate services for the improvement of programs. As well as developing, implementing, and maintaining a comprehensive/strategic Continuous Quality Improvement (CQI) program for research programs within the Research Enterprise. Show less

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  BreatheAmerica, Inc

  May 2015 - Jun 2019

  Director, Clinical Research & Compliance

  Responsible for leadership of the Clinical Research program, including regulatory and fiscal oversight of all projects and staff. Charged with ensuring the development of operational infrastructure and strategic initiatives that are supportive of the organization’s goals and priorities by selecting and implementing studies that enhance BA's mission to provide comprehensive care and that contribute to building the organization's reputation as a leader in clinical research.

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  Vanderbilt University Medical Center

  Apr 2017 - Nov 2021

  Responsible for Clinical Research Operations within the Vanderbilt Ingram Cancer Center (VICC) with an emphasis on data management, regulatory oversight, coordination of multi-site clinical trials, and strategic process development across the research enterprise.VICC is one of 53 National Cancer Institute-designated Comprehensive Cancer Centers, dedicated to an integrated and patient-focused approach to cancer research, treatment, support, prevention, education and outreach. The Clinical Trials Office provides services to assist Cancer Center investigators in developing, activating and completing scientifically meritorious clinical trials in an efficient, cost-effective and technically sound manner. Show less

  • Director, Clinical Research Administration, Vanderbilt-Ingram Cancer Center

    Dec 2018 - Nov 2021

  • Assistant Director, Clinical Trials Shared Resource, Vanderbilt-Ingram Cancer Center

    Apr 2017 - Dec 2018
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  Florence Healthcare

  Nov 2021 - now

  Chief Clinical Trial Officer

  Florence enthusiast and subject matter expert focused on building connectivity platforms that help clinical trial sites and sponsors modernize and revolutionize the clinical trials process. Executive oversight of Customer Strategy, Global Compliance and Thought Leadership teams. Florence is a high growth (Inc. 500, 1,000% growth) B2B SaaS Series C company backed by Insight Partners, Fulcrum Equity Partners, and Bee Partners that develops software for clinical research organizations (Healthcare systems, Med Device, Pharma) globally. Show less

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  Clinical Trials Transformation Initiative (CTTI)

  Jan 2022 - now

  Steering Committee Member

  The Clinical Trials Transformation Initiative (CTTI) was co-founded by Duke University and the U.S. Food and Drug Administration in 2007 in an effort to identify and address challenges to well-designed, properly executed clinical trials, and offer recommendations to improve and modernize research.CTTI fosters an open forum for all stakeholders - 500+ organizations and approximately 80 member organizations - to discuss issues, exchange ideas, and come to a consensus on solutions. Through this unique approach of blending diverse viewpoints, our work is actionable; it helps re-shape policies and procedures across the research community to run more efficient trials, generate high-quality evidence faster and, - ultimately - improve the health of people. Show less

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  Association of Clinical Research Organizations (ACRO)

  Nov 2022 - now

  Board Member

  ACRO advocates as the collective voice of innovative clinical research and technology organizations to regulators and policymakers, educating stakeholders and shaping policies that foster efficient, effective and safe conduct of clinical research.

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  GCSA - The Global Quality Standard for Clinical Research Sites

  Jan 2024 - now

  Board Member

  GCSA provides a system of assessment, gap analysis, process improvement and independent quality assurance certification across 7 key modules.The best practice standard was developed with a Global Advisory Board of clinical research industry stakeholders. Their shared ambition is to ensure process excellence that facilitates synergistic partnerships between sites and sponsors to ensure true patient centricity.

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  ACRP - Association of Clinical Research Professionals

  Jan 2024 - now

  Board Member

  With more than 16,500 members, the Association of Clinical Research Professionals (ACRP) is the only non-profit organization solely dedicated to representing, supporting, and advocating for clinical research professionals. ACRP supports individuals and life science organizations globally by providing community, education, and credentialing programs. Founded in 1976, ACRP is a registered 501(c)(3) charitable organization whose mission is to promote excellence in clinical research and whose vision is that clinical research is performed ethically, responsibly, and professionally everywhere in the world. Show less