Karishma Sookraj

Experience

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  FIMRC: Foundation for International Medical Relief of Children

  Sept 2020 - Nov 2020

  Practicum Student/Global Health Fellow

  Gained a deeper understanding of global and public health issues such as healthcare systems throughout Africa & Asia and the challenges presented through training modules and journal article readings. Worked in varied aspects of public health that are not wholly clinical to better understand the need for a diverse approach to be most effective at making gains in quality of life and health and became familiar with global development initiatives and organizations. Participated in training modules focusing on the most common diagnoses seen through the FIMRC Latin America sites including their epidemiology, diagnostic tests and procedures, clinical presentation, and recommended treatment. Show less

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  Columbia University Irving Medical Center

  Dec 2020 - now

  Ensures protocol compliance for all patients on Phase II/III clinical trials while adhering to COG, National Cancer Institute (NCI), Food and Drug Administration (FDA), Good Clinical Practice (GCP), and both central and local IRB regulations and develops strategies to enhance institutional performance by promptly resolving data queries and addressing delinquent forms issued by the COG Data Center. Manages the COG institutional member roster and assists study team in obtaining access to CTSU website through Cancer Therapy Evaluation Program - Identify and Access Management (CTEP-IAM) and provides support to study team for registering in the National Cancer Institute (NCI) Registration and Credentialing Repository (RCR). Distributes COG announcements, including weekly newsletters and urgent action alerts, to the study team, along with information from the NCI Clinical Trials Support Unit (CTSU) and assists with organizing and facilitating COG audits and collaborates with the study team to address audit findings and implement corrective actions. Creates the departmental quarterly newsletter, highlighting divisional changes and updates on clinical trials. Show less Leads Phase I/II industry-sponsored clinical trials coordinated by the Pediatric Cancer Foundation Developmental Therapeutics Program (PCFDTP) at CUIMC, focusing on advancing new treatments for children with high-risk cancers, and oversees a team of seven, driving site readiness to ensure compliance and performance standards are met in preparation for monitoring visits and FDA audits. Collaborates with the research pharmacy during quarterly meetings to ensure accurate drug accountability records and drug compliance for all research patients. Ensures accurate data entry into Velos, IBM Clinical Trial Management System (CTMS), Epic, and Medidata to support patient recruitment, budgeting, electronic data capture, and data safety monitoring. Provides study status reports and brief summaries of patient progress during weekly team meetings, and leads onboarding and training for new employees, covering standard procedures and best practices. Show less Facilitated daily trial activities with the principal investigator (PI) and sponsors on early drug development trials sponsored by the PEP-CTN and Therapeutic Advances in Childhood Leukemia/Lymphoma (TACL) as well as investigator-initiated and industry sponsored studies. Supported the PI in informed consent process, ensuring compliance with ethical and regulatory standards, and coordinated and scheduled physical exams, radiology, and laboratory tests, while notifying the clinical team of upcoming patient appointments and outstanding research tasks. Managed and organized study monitoring visits with investigators and external monitors, ensuring the accurate preparation of source documents and IRB documentation. Assisted the regulatory coordinator with the preparation and submission of all protocol-related documents, including applications, amendments, continuing reviews, informed consent forms, and safety reports, for review and approval by local and central IRBs. Show less Assisted with grant-funded clinical research studies focused on the prevention of HIV and COVID-19. Daily tasks included: screening potential participants to assess eligibility for study participation, scheduling and confirming participant study visits and follow-up appointments, completing study-specific data collection from various sources into REDCap and Medidata, and maintaining source documentation in accordance with protocol guidelines. Oversaw the collection and transportation of study specimens to the research laboratory and ensured timely request and delivery of study drugs from the research pharmacy to the site. Implemented continuous quality improvement processes to maintain the integrity of data collected and entered into study databases, and employed targeted strategies to track and retain study participants, and re-engage those missing study visits. Show less

  • Children’s Oncology Group (COG) Lead Clinical Research Associate (CRA)

    Oct 2023 - now

  • Clinical Research Coordinator I

    Jul 2023 - now

  • Clinical Research Coordinator

    Mar 2022 - Jul 2023

  • Program Outreach Assistant

    Dec 2020 - Mar 2022