Natalie K. Bongiorno
Arlington,USA
Summary
With over 25 years of leadership in oncology clinical research, including pivotal roles at The Center for Cancer and Blood Disorders, I excel in strategic study operations and team development. My expertise in cancer genomics and advanced research skills, coupled with a talent for fostering clinical research collaborations, has significantly enhanced program success and efficiency.
Overview
24
24
years of professional experience
1
1
Certification
Work History
Director of Research Operations
The Center for Cancer and Blood Disorders (American Oncology Network)
Bethesda, MD
05.2004 - Current
- Oversee program execution of 600+ Oncology/Hematology clinical trials, including risk management, enrollment, and quality oversight
- Provide strategic leadership in financial planning, project budgets, forecasting, invoice approvals, and resource allocation
- Recruit, mentor, and develop clinical operations teams
- Lead selection, contracting, and budget management activities for clinical trials
- Ensure regulatory compliance and quality checks for clinical trials
- Drive SOPs, process improvements, and work instructions for clinical operations
- Lead the integration of CRO/Sponsor resources for efficient trial execution
- Direct and assess research staff performance to align with company standards and goals
- Manage strategic study operations, regulatory submissions, and performance metrics
- Develop tracking tools for budgets, timelines, and deliverables; monitor project progress
- Identify issues in program execution and implement corrective actions
- Lead clinical trials across the oncology treatment landscape including First in Human Phase 1 to Phase IV and Real world based evidence trials, ensuring timely execution of patient, sponsor, company, financial and regulatory goals
- Develop study delivery strategies, focusing on patient recruitment and engagement
- Manage practice, vendor and CRO relationships to align with study objectives and site goals
- Act as the primary contact for clinical trial execution
- Ensure trial menu aligns with the needs of the practice
- Implement technology and software for better operational and fiscal outcomes
- Manage performance and development of the clinical operations team, fostering prioritization and problem-solving
- Provide coaching and support to research staff and managers to align with goals
- Recruit and train clinical operations talent, improving efficiency and performance
- Lead continuous improvement initiatives to enhance productivity and streamline operations
- Collaborate with physicians, executive leadership, and research teams for protocol alignment and regulatory compliance
- Partner with Pharmaceutical companies, Medical Science Liaisons, Key Opinion Leaders, Contract Research Organizations, and Site Management Organizations for trial engagement and capabilities
- Act as the main point of contact between sponsors and clinical sites, ensuring compliance with trial operations
- Support site staff recruitment, training, and retention, educating on protocols and timelines
- Collaborate with internal teams to ensure high-quality site management
- Analyze trial progress and data to drive decision-making and resolve challenges
- Track site performance, identify risks, and develop solutions to enhance trial progress
- 25 years of Hematology/Oncology Clinical Research Operational Leadership experience
- Created the research infrastructure and operational roles from early inception of the company
- Oversee 90+ Oncology/Hematology trials simultaneously
- Work with cutting edge research drugs throughout the drug development landscape including CAR-T, Bi-specifics, Antibody Drug Conjugates and Precision Medicine
- Developed clinical research strategies and tactics for one of the largest and successful community oncology research programs on the East coast
- Managed project activities in clinical science, data management, regulatory affairs for over 600 Hematology/Oncology clinical trials
- Provide expertise in patient-centered clinical study education and engagement
- Serve as a Key Opinion Leader on Clinical Research Operations, Budget negotiations, and Oncology and Hematology Clinical Trials
- Achieve research metrics, including enrollment goals, and negotiate budgets and contracts
- Maintain financial oversight for all clinical trials
- Working on a program initiative for AI software integration with clinical trial matching with molecular sequencing and data aggregation across multiple disciplines
- Spearhead and collaborate on practice initiatives for expansion and growth
- Enforce compliance with NIH, GCP, SOPs, and FDA requirements
Director of Clinical Operations
The Center for Cancer and Blood Disorders
Bethesda, MD
01.2014 - 05.2020
- Manage all clinical staff on day-to-day basis to improve clinic flow among all departments for better patient/physician interaction
- Mentor the supervisors on how to be efficient leaders and function for the staff as a clinical advocate
- Direct supervisor for Oncology Infusion Center and pharmacy at two locations
- Led the transition from paper records to an Electronic Medical Records System in 2008
- Streamline communication among the clinical departments (Nursing, Lab, Medical Assistants, Infusion, Mid-level Providers, Physicians)
- Create policies and procedures for clarity and measurements for accountability within the clinic
- Serve as back-up Practice Administrator in their absence and function as the resource for all staff and physicians on all tasks
- Ensure all quality metrics are created and met for PQRS, MIPS, and all measures mandated for provider services reimbursement
Director of Research Operations
National Capitol Clinical Research Consortium
Bethesda, MD
01.2008 - 12.2012
- Implemented the creation of a multi-practice oncology research consortium in Washington, DC metropolitan area
- Provided research infrastructure for 7 practices and 16 physicians to access participation in 25 clinical trials through our research network
- Restructured offices and produced Standard Operating Procedures in accordance with mandated guidelines for conducting clinical trials
- Regularly make site visits to discuss current and upcoming clinical trials with physicians and key practice staff members
- Trained and educated the physicians and nurses on the fundamentals of clinical research to the specific drug product that was being tested in trial
Clinical Research Program Coordinator
Washington Hospital Center/GYN Oncology
Washington, DC
02.2003 - 05.2004
- Oversaw and facilitated gynecologic oncology clinical trials by recruiting, screening, enrolling, and providing follow-up care to meet the requirements of protocol
- Functioned as the case manager and primary nurse for all the research patients
- Maintained all records for drug accountability in coordination with the pharmacist
- Complied with the Institutional Review Board through submission of all regulatory documents to conduct research
- Acted as a data manager through monitoring and reporting of side effects, disease status, and clinical adherence per guidelines
Clinical Research Nurse/Coordinator
Cardiology Associates, PC
Washington, DC
10.2002 - 01.2004
- Conducted all aspects of clinical study by recruiting, screening, enrolling, and providing follow-up care to meet the requirements of the cardiac research protocol
- Developed enrollment and follow-up guidelines for each protocol and create tools to satisfy all sponsor requirements
- Completed Case Report Forms and provide accurate source documentation in a timely manner
- Coordinated the initiation, maintenance, and closure of protocols in accordance to the guidelines of the Institutional Review Board
- Ensured compliance with Good Clinical Practice Guidelines
Clinical Research Nurse/Coordinator
Oncology Of Wisconsin, SC
Milwaukee, WI
12.2000 - 10.2002
- Functioned as a liaison between the oncologist and subject in the initiation, implementation, and evaluation of oncology clinical trials
- Educated physicians, clinic staff, patients, and families regarding specific protocol requirements, procedures, side effects, risks, and follow-up care
- Acted as a data manager through monitoring and reporting of side effects, disease status, and clinical adherence per guidelines
- Served as a resource for colleagues and an advocate for the patients and families
Education
Master of Science - Health Sciences, Clinical Leadership Program for Health Professionals, Concentration in Clinical Research Administration
The George Washington University
Washington, DCBachelor of Science - Nursing
University of Iowa
Iowa City, IASkills
- Advanced research skills
- Clinical research collaboration
- Cancer genomics
- Clinical Research Analysis
- Pharmacy practice research
- Treatment and research records
- Provider research
- Cancer Diagnostics
Certification
- Wisconsin, 07/03/01
- Virginia, #0001197914, 07/31/05
Publications
Electronic medical records and standardized data could mean a boost in clinical trials enrollment-Commentary, Boccia, R., Bongiorno, N., Community Oncology, 4, 7, 1-5, 2007
Timeline
Director of Clinical Operations
The Center for Cancer and Blood Disorders
01.2014 - 05.2020
Director of Research Operations
National Capitol Clinical Research Consortium
01.2008 - 12.2012
Director of Research Operations
The Center for Cancer and Blood Disorders (American Oncology Network)
05.2004 - Current
Clinical Research Program Coordinator
Washington Hospital Center/GYN Oncology
02.2003 - 05.2004
Clinical Research Nurse/Coordinator
Cardiology Associates, PC
10.2002 - 01.2004
Clinical Research Nurse/Coordinator
Oncology Of Wisconsin, SC
12.2000 - 10.2002
- Wisconsin, 07/03/01
- Virginia, #0001197914, 07/31/05
Master of Science - Health Sciences, Clinical Leadership Program for Health Professionals, Concentration in Clinical Research Administration
The George Washington University
Bachelor of Science - Nursing
University of Iowa
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