Erika Jerome

Experience

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  Philadelphia FIGHT

  Apr 2009 - Mar 2012

  Institutional Review Board Coordinator

  • Facilitated monthly meetings for Philadelphia FIGHT's local Institutional Review Board (IRB).• Edited and maintained the IRB's Manual of Operations. • Served as the liason for the FIGHT research department, IRB and pharmaceutical sponsors.• Submitted and maintained regulatory documentation for all clinical and investigator-sponsored research studies.

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  Philadelphia FIGHT

  Dec 2012 - Nov 2015

  Quality Assurance Coordinator

  • Authored the strategic plan for quality management department. • Managed all data and performance reporting for outpatient ambulatory care department. • Developed quarterly and annual reports for federal funders. • Facilitated monthly meetings for the quality management committee, and aided and reported all quality management projects to funders to secure grant funding and ensure quality of care to patients

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  Fox Chase Cancer Center

  Dec 2015 - now

  ● Oversight and management of protocol development and monitoring team within the Investigator-Sponsored Research Unit● Maintains oversight over the development of standard operating procedures to codify processes within the department● Assesses priorities and adjusts allocation of resources to increase efficiency and effectiveness within the department● Collaborates closely and maintains working relationships with clinical team leads, physicians, and upper management ● Provide consultation and support to direct reports and ensure understanding and compliance to all applicable regulatory requirements and guidance Show less • Supervised the monitoring team of the Investigator-Sponsored Research Unit (ISRU)• Oversight of activities as described in monitoring plans, study protocols, ICH guidelines, and federal regulations.• Reviewed TRIP reports/monitor visit reports, track scheduling, report submission metrics, site deviations, AEs/SAE tracking and action items for the assigned studies per disease site• Oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation, and corrective actions. • Development of training materials and study tools for site and CRM use• Assessed priorities and competing demands and adjusts allocation of resources to increase efficiency and effectiveness of workflows Show less • Monitored all investigator-sponsored oncology trials for the Breast, GI, and Radiation teams. • Facilitated the activation of external academic sites and liaised between the study teams and the sponsor. • Assisted in facilitating the Data Safety Monitoring Board's meetings and correspondence with study teams. • Ensured compliance with the protocol, standard operating procedures, and good clinical practice (GCP) as well as FDA/ICH guidelines. • Maintained the trial master files (TMF) for all assigned studies and assures the completion of regulatory documentation Show less

  • Manager of the Investigator Sponsored Research Unit

    May 2022 - now

  • Clinical Trial Monitor Lead

    Jan 2021 - May 2022

  • Clinical Trial Monitor

    May 2019 - Jan 2021

  • Regulatory Coordinator

    Dec 2015 - May 2019
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  University of Delaware

  Jun 2024 - now

  Instructor

  Offered through UD’s Division of Professional and Continuing Studies (UD PCS), the self-paced and interactive curriculum includes broad coverage of U.S. and worldwide clinical trial processes and regulations, data management, legal and ethical considerations, and marketing principles.