Laura Federico

• Administer safe and accurate daily radiation treatments according to prescription provided by the Radiation Oncologist, prescribed protocols/parameters, and relevant patient safety standards, ensuring efficient treatment delivery with maximum possible patient satisfaction
• Operate radiation therapy delivery systems and sub-systems (including daily QA on treatment units, record & verify, x-ray and CBCT), ensuring optimal functionality and safety compliance
• Verify proper patient positioning for accurate delivery of radiation therapy sessions, following established department policy, and complete Imaging Department training for CT Simulation including construction of immobilization devices and CT scans of initial patient set-up for treatment planning
• Document treatment course progress in electronic health records for effective tracking, monitor patients for both usual and unusual reactions/events and reporting occurrences as needed to the Radiation Oncologist or Nurse
• Perform initial and periodic chart checks for completeness of documentation and ensurance of compliance with department quality management plans (QMP)
• Work with patient, family, and support services to schedule patients and maintain coordination of treatment-related activities, perform patient education to ensure understanding of treatment procedure and possible reactions
• Orient and educate Radiation Therapy students, participate in performance appraisal for students and other therapists and in department meetings, retraining and continuing education activities

Supervisor for three teams of Clinical Research Coordinators (1/2018-8/2018)

• Perform and oversee daily operations of clinical research study conduct, ensuring compliance with all regulatory requirements, policies, and quality standards as set forth by the FDA, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), study sponsor, Internal Review Board (IRB), and Clinical Trials Office (CTO)
• Perform leadership and personnel management duties including conflict resolution, training and mentoring of team members on operational procedures and best practices, and all research study management duties in close collaboration with physicians and lead investigators, protocol nurses, and internal regulatory departments (IRB, CTO)
• Improve workflow efficiency by implementing process optimizations and resource allocation strategies
• Conduct performance evaluations, providing constructive feedback to enhance team productivity

Clinical Research Coordinator (7/2004-9/2013 and 4/2016-1/2018):

• Perform all the duties required to manage multiple and simultaneous in-house, Pharmaceutical, Cooperative Group, and Independent Consortium Group clinical trials for the Radioimmunotherapy and Thoracic teams

Clinical Research Associate (CRA) I (7/2004-7/2005), CRA II (7/2005-3/2012), CRA III (3/2012-9/2013)

NOTE: Gap in employment (9/2013-4/2016) for return to full-time Pre-Med education

Clinical Research Associate (CRA) II (4/2016-2/2017), CRA III (2/2017-1/2018)

• Manage clinical treatment trials conducted by the Radioimmunotherapy team at the Center for Immunotherapeutics and Tumor Immunology, as well as several Pharmaceutical and Cooperative Group studies.
• Screen patients for trial participation, organize and oversee all aspects of participation
• Create and maintain all patient and protocol research files
• Collect comprehensive toxicity and diagnostic data for biostatistical analysis
• Draft and submit new and amended protocols and manage all other regulatory requirements to ensure continual overall and ongoing compliance with FDA regulations and those of ICH/GCP
• Conduct comprehensive weekly patient and protocol status presentations to the research team
• Routine performance of specialized tasks as required including assistance with budget issues, scientific literature searches, and drafting of protocol abstracts to help drive new research and trials forward
• Interview, train, and supervise junior colleagues and assistants to myself and my direct team members