The Innovations Nurses and Clinical Coordinators Want for Remote Clinical Trials

Bert Hartog, PhD is currently Senior Director, Clinical Innovation at Janssen R&D Operations, where he leads transformational innovation projects that have the goal to shape the future of clinical trial execution at Janssen and position Janssen as a role model in patient-centered clinical research.Dr Hartog is a professional in the pharmaceutical industry, with 20+ years’ experience in Clinical Operations, QA, IT and Project Management. He started his career with a Masters in Biomedicine from Utrecht University in the Netherlands, as CRA with Eli Lilly. During this time he completed his PhD in Medicine at Utrecht University. In 1998, he moved to London to start work as head of Medical Quality Assurance with responsibilities for the EMEA region. In this role, he introduced risk self-assessment tools for local clinical operations departments. In 2001 he became IT manager at Lilly’s R&D site in the UK. In this role, he established a PMO and got deeply involved in project management. In 2005 he left the UK to start work at Johnson & Johnson from Belgium; first in corporate IT & compliance where Sarbanes-Oxley was first introduced. In 2008 he returned to his passion in clinical research, as Director Clinical R&D with Janssen, where he led the clinical operations departments in the Benelux and Nordic countries for 4 years. With this experience, he joined a large transformation program at Janssen’s clinical development operations. His responsibilities included the introduction of a new CTMS and a next generation eTMF solution, as well as setting up a new business function to own these technical capabilities. Since summer 2015 he has become part of the Janssen R&D Operations Innovation team.

Jennifer Hedglin, RN, is Clinical Research Nurse in the Center for Cancer Therapeutic Innovation at Dana Farber Cancer Institute. For the first six months of the pandemic, Ms Hedglin along with Newly Licensed Research Nurses were redeployed to the investigational drug supply shipping project that oversaw the shipping of oral investigational medications to patients in clinical trials.

Juli Madzsar, RN, BSN, HNB-BC is a neurology clinical trial nurse at Memorial Sloan Kettering Cancer Center. Ms Madzsar received her BSN in 2013 from Ohio State University and began her career at the Cleveland Clinic neurological intensive care unit, where she also served as a Vice President of Shared Governance and was a member of the hospital- wide committee working to improve nursing documentation.At Memorial Sloan Kettering Cancer Center (MSKCC), Ms Madzsar works in Phase I-III neurological trials where she reviews research protocols in development, serves as a primary informational source, implements standards in compliance with regulatory, institutional, and external agencies, and manages and assess patients’ symptoms. While at MSKCC, Ms Madzsar has been published twice for her involvement in research surrounding CNS Lymphoma in the studies “Phase Ib of Copanlisib in Combination with Ibrutinib in Recurrent/Refractory Primary CNS Lymphoma (PCNSL)” and “CTNI-61. Pilot Study of Repeated Planned Glucarpidase Following High Dose Methotrexate (HD-MTX) in CNS Lymphoma (CNSL)”. She also initiated a weekly meeting of neurology nurses spanning all regional MSKCC locations and developed a tracking tool to ensure siloed nursing teams are aligned on patient needs and best practices, leading to improved collaboration and care. Ms Madzsar looks forward to incorporating and advancing her holistic practice in the future. She is currently enrolled in an Adult-Geriatric Nurse Practitioner program at CUNY Hunter College on track to graduate in 2022, with a plan to continue her education to receive her Doctor of Nursing Practice Degree.

Shea Overcash is the Senior Manager of Quality Assurance at Javara, the leading Integrated Research Organization (IRO) providing comprehensive clinical research infrastructure to healthcare organizations to expand access to clinical trials at the point-of-care. With nearly thirteen years in clinical research, her background includes previous experience as a Clinical Research Coordinator at PMG Research and involvement with several multispecialty trials, including device studies. Ms Overcash also served as a clinical research team member on multiple COVID-19 vaccine studies with Javara in 2020. Passionate about training and development, her commitment to improving processes, increasing efficiencies, and ensuring high quality outcomes for clinical research is exemplified by the Quality Management System Policy she developed for Javara. Ms Overcash received her bachelor’s degree in biology from the University of North Carolina at Asheville.

Cameron Sze, BSN, RN is a Clinical Trials Nurse at Dana-Farber Cancer Institute. Within her current role she manages the new hire orientation for Research Nurses including curriculum development and management as well as the Research Nurse Track for the Nurse Residency Program. Prior to Cameron’s current role she worked as a Research Nurse in the Phase 1 Early Drug Development Center at Dana-Farber managing a large portfolio of Phase 1 clinical trials in varying disease groups across the Institute. In addition to her work experiences, Ms Sze is an active member of the Oncology Nursing Society and manages the Boston Chapters online platform. She is also an active member of the International Association of Clinical Research Nurses, and Secretary of the Boston New England Chapter. She is the co-author of the Study Conduct and Participant Care Chapter of IACRNs Core Curriculum due to release early next year.