University of Maryland, Baltimore (UMB)Clinical Research Specialist
Jul. 2019 - Aug. 2020Spearheaded an average of 6-8 phase I through III clinical trials and provided clinical research management overseeing protocols in hematological malignancies, including, but not limited to, cellular therapies, immunotoxins, ADCs, mAbs, and small molecule kinase inhibitors, etc, while: • Served as the primary liaison to oncology physicians, CROs, study sponsors, inpatient clinical staff to ensure proper study execution, data collection and adverse event reporting. Led • Trained clinical research staff, ensuring compliance with protocols and study objectives. Responsible for quality control, study compliance and approving cancer center drug order forms for clinical trials. • Developed project timelines, work plan, recruitment strategy and progress through the duration of the clinical trial. Assisted with the development and maintenance of study materials and databases. Guided Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials. Improved workflow by 20%. • Oversaw day to day clinical research operations and leading study initiation, execution, and completion. Oversaw interactions with subject participants including eligibility screening, recruitment, enrollment, informed consent, counseling, and obtaining patient medical history. • Trained, directed, assigned duties to & supervised research staff, students, residents &/or fellows. Acted as a mentor in regard to education of junior coordinators. • Serves as a scientific resource/expert to patients, PIs, and key stakeholders to support research activities.