Simonnette Lucas, MPH, CIP, CCRP

Experience

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  House of Keesan Inc

  Jan 2004 - Jun 2004

  Manager

  Managed all aspects of the factory by: ensuring compliance with USDA regulations; ensured product quality; handing customer complaints and ensuring quality customer service; hiring all employees, serving as mediator for employee disputes and doing payroll.

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  Mercy Hospital

  May 2004 - Jan 2005

  OD Associate

  Coordinated education registration and tracking; conducted training for new hires (OSHA compliance, hospital policies, etc.); facilitated the Tuition Assistance Program; guided employees on career development and provide advice on college programs; served as office manager; and coordinated monthly and annual employee recognition and rewards programs.

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  Mercy Hospital

  May 2005 - Jul 2006

  IRB Administrator

  Managed all IRB services for the hospital by: creating and developing training modules and packets for IRB members and hospital staff; serving as liaison between the IRB members and the research community; acting as primary resource for principal investigators; conducting audits of all studies managed by the IRB; ensuring the hospital complied with both state and federal regulations; and drafting the IRB’s budget for the Director of Medical Staff.

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  University of Miami

  Jul 2007 - Apr 2020

  • Re-structure and streamline current processes as well as implementing new processes within the Research Committees in order to attain NCI designation. • Oversee the research committees of the cancer center (Protocol Review and Monitoring Committee (PRMC), Feasibility Review Committee (FRC), and Data Safety Monitoring Committee (DSMC) and the support staff to ensure compliance with CCSG guidelines. • Ensure the PRMC and DSMC functions are managed per the requirements outlined in the CCSG. • Develop and continually assess SOPs, submission forms, data collection tools, and systems needed to facilitate efficient and accurate reporting as required by the CCSG guidelines for the PRMC and DSMC. • Implement a Bio-Behavioral/Population Science PRMC with support staff in order to meet the CCSG guidelines. • Implement a FRC with support staff in order to facilitate the opening of quality studies in the SCCC research portfolio. • Define and compile metrics of protocols reviewed by the committees (PRMC, DSMC and FRC) as well as the Site Disease Groups (SDGs). • Support and oversee the goals set by the Clinical Research Internal Advisory Board (CRIAB) that evaluates all aspects of the clinical research enterprise and makes recommendations on all issues related to clinical study activities. • Help identify barriers to clinical research, prioritize, plan and propose achievable action items. • Utilize project metrics to ensure employees understand their roles and functional areas while taking ownership of driving results.• Set departmental and individual employee goals and provide routine evaluations of progress toward these goals. Identify and promote professional growth opportunities for staff while ensuring adherence to professional standards and research ethics.• Develop and oversee budgets and policies and procedures for the Research Committees Support Unit.• Ensure SCCC meets its strategic goals in research as articulated in the vision and strategic plan. Show less Manage the operation of a 9-member ethics board in addition to two administrative supporting staff. Facilitate bi-weekly board meetings (including scheduling/logistics, meeting notifications, agenda/meeting materials distribution, confidential maintenance of meeting documentation, etc.).Serve as a voting member of the IRB and review all items listed for review. Coordinate/Facilitate the enrollment for subjects from external sites (international, out-of-state or another facility within Florida). Communicate with high-level stakeholders in regards to IRB determinations and needs. Conduct extensive regulatory reviews of full board high-risk research protocols, in accordance with Florida law, institutional guidelines, Health Insurance Portability and Accountability Act (HIPAA), Department of Health and Human Services (DHHS) and Federal Drug Administration (FDA) regulations relating to good clinical practice and clinical trials. Reviews included studies involving Investigational New Drugs (INDs), Investigational Device Exemptions (IDEs), and Humanitarian Use Devices.Train new employees on HSRO policies and procedures and all applicable federal and state regulations.Facilitate the implementation of the online research system (eProst) and IRB 7. Conduct regulatory reviews and IRB reviews/approvals on low risk expedited and exempt protocols according to DHHS regulations and institutional policies.Review research-related sponsor agreements/contracts, the informed consent process for study participants and other study materials to ensure compliance.Review and prepare protocol deviations and serious adverse events for review by the IRB chair and/or the full IRB.Ensure minutes taken at IRB board meetings are complete and prepare the final version for review by the University of Miami Institutional Official and IRB members. Maintain accurate records of IRB paper and electronic files. Show less

  • Director, Research Committees - Sylvester Cancer Center

    Nov 2015 - Apr 2020

  • Non-Scientist IRB Member/IRB Senior Regulatory Analyst

    Jul 2007 - Oct 2015
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  University of Miami - Susan G. Komen Grant

  Aug 2014 - Nov 2014

  Project Monitor

  Created a monitoring process to support compliance with applicable regulations; reviewed study charts to ensure compliance with the IRB approved protocol and applicable regulations; ensured the consenting process and study procedures were conducted in accordance the applicable regulations; and ensured the sample collection and shipping process were conducted according to the applicable guidelines.

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  Miami Cancer Institute, Baptist Health South Florida

  Apr 2020 - now

  Manages and oversees the Miami Cancer Institute (MCI) Human Research Protection Program (HRPP). Interprets and implements federal regulations, Florida statutes, and MCI policies regarding the protection of human subjects in research. Serves as the primary resource for regulatory and ethical guidance, providing direction for Institutional Review Board (IRB) members, investigators, IRB Specialist and staff, institutional officials, and the research community. Serves as a member of the IRB as appropriate and ensures IRB roster is compliant with the federal Office of Human Research Protections (OHRP) and U.S. Food and Drug Administration (FDA) requirements for membership. Oversees FDA and/or OHRP audits or investigations of noncompliance. Manages program reporting, budget, cost analysis, training, and personnel. Manages the Research Compliance Program, which is part of the Office of Research Integrity (ORI). Ensures compliance with federal regulations, state law, and MCI policies related to the conduct of human subjects research. Manages the program reporting, budget, cost analysis, and personnel. Develops, implements, and evaluates policies and procedures. Oversees related training programs. Oversees investigations of noncompliance and resolves issues. Oversees the development and monitoring of management plans, working with Investigators and all applicable parties. Show less

  • Director, Office of Research Integrity

    Apr 2021 - now

  • Manager, Office of Research Integrity

    Apr 2020 - Apr 2021