Part-Time Family Practice
Resume:
Antonietta D’Addio
*********@*****.***
Resume Highlights
VA, Seattle, WA
Created and submitted more than 45 contracts in less than six months. Created an extensive spreadsheet used by Senior Leadership for training purposes for Contract Officer Representatives.
Brought a two-year back-log of Subject Payment Requests current in less than three months; was a key contributor to changing the submission and payment process that minimized turn-around time from ten weeks to three days. Wrote Subject Payment Request SOPs for Department SharePoint site and trained Study Teams on new system.
VA, Denver, CO
Created a REDCap database for new study’s CRFs, screening logs and data capture forms. Researched and created extensive spreadsheet of fitness venues for geriatric patient demographic for national distribution to healthcare providers that is, to date, still in use.
Johns Hopkins School of Public Health
Increased enrollment to epidemiological studies by one third and improved patient follow-up 25%.
Departments of Anesthesia and Critical Care and Family Practice and Community Medicine
Wrote INDs for both Departments that required me to learn the science of the protocol in order to apply for the off-label use of FDA-approved drugs.
Antonietta D’Addio Resume
Veterans Administration Healthcare System
Research & Development Administrator, Boston, MA (Feb, 2024-Jan, 2025)
Reviewed Amendment, Study Closure, Continuing Review and Biennial submissions for accuracy and verification of training certifications, Conflicts of Interest and Research Certification Appointment Letters.
Provided feedback to PIs and study teams for required revisions prior to full committee review.
Generated/published minutes and approval letters; assisted in building the bi-weekly agenda for committee meetings. Work performed using VAIRRs.
Monitored Privacy and DUA processes.
Research and Development Administrative Specialist (Term App’t), Seattle, WA (June, 2022-Feb, 2024)
Reviewed acquisition requests for accuracy and adherence to regulatory mandates. Amended Statements of Work. Recommended changes to Study Team. Created FORCE and 2237 submissions in VISTA.
Resolved discrepancies between vendors and contracting officers.
Created Excel spreadsheet to monitor contracts from submission to award that was used as a training tool for new contract staff training.
Processed two year back-log of Subject Payment Requests in three months using LEAF, VISTA and DocuSign.
Responsible for monitoring budgets and requesting additional funds to meet forecasted obligations.
Member of the Process Improvement Team for replacing an inefficient system of submitting payment requests and decreased turn-around time from a minimum of ten weeks to three days.
Wrote instructions for SharePoint, trained Study Teams on preparation and submission of payment requests.
Research and Development Clinical Research Coordinator (Term App’t), Denver, CO (Oct, 2021-June, 2022)
Marketing Lead for Medical Foster Home initiative. Wrote sections of brochure for external and internal audiences.
Recruited Veterans and conducted grounded interviews for RECAP study.
Wrote interview guide used to conduct grounded interviews with VA Public Affairs Officers at VA and external constituents. Performed literature searches.
Created weekly agendas for team meetings then led and generated minutes for meetings.
Created database in REDCap consisting of CRFs, screening logs and data capture forms for new study.
Million Vet Program Program Specialist (Term App’t), Reno, NV (Jun, 2019-July, 2019)
Institutional Review Board Program Assistant, Cleveland, OH (Jan, 2018-Aug, 2018)
Reviewed and evaluated IRB submissions for accuracy and compliance with state and federal regulations.
Monitored Study Teams’ certification requirements. Approved expedited, administrative submissions.
Created and updated monthly agenda. Generated reports for board members from SharePoint. Reviewed new protocols with R&D.
Madigan Army Medical Center
Pediatric Oncology Protocol Coordinator, Tacoma, WA (July, 2019-Oct, 2020)
Prepared study start-up/closures, modifications and continuing reviews to external and local IRBs and national regulatory agencies. Generated reports from numerous databases.
Reviewed, analyzed and submitted Adverse Events in CTEP-AERS. Monitored CTEP Certification requirements.
Registered/randomized subjects; processed and shipped biospecimens; completed CRFs in iMedidata and RAVE.
Monitored and replenished inventory supply for multiple studies ensuring payments were charged to correct grant.
Dartmouth School of Medicine
Clinical Research Coordinator (Term App’t), Hanover, New Hampshire (Aug, 2015-Jun, 2016)
Identified, recruited and consented patients to study.
Used bedside ultra-sound to measure IVC and jugular veins during patients’ hemo-dialysis treatment.
Trained Research Assistant in GCP. Made recommendations to PI for study design.
Created/completed CRFs for data collection. Ensured HIPPA compliance of source documentation.
Managed inventory and ordered study supplies.
Obtained authorization from Radiation Safety for Study-related equipment used in clinic.
Boston Children’s Hospital
Emergency Medicine Administrative Associate (Term App’t), Boston, MA (Dec, 2014-Apr, 2015)
Curated on-line Ebola media alerts.
Johns Hopkins School of Public Health
Department of Epidemiology, Baltimore, MD (May, 2010-Mar, 2016)
Interviewer Department of Immunology (Part-Time). Conducted extensive interviews and neuro-psych evaluations with HIV+ patients for long-standing, epidemiological study.
Research Assistant/Recruitment Coordinator, Department of Epidemiology (Full-Time). Patient recruitment to pulmonary studies. Managed two studies requiring pre- and post-ART onset bronchoscopies with an 85% success rate.
Project Supervisor, Department of Epidemiology (Full-Time). Managed pulmonary including regulatory submissions, data cleaning, coding and analysis. Created budgets and monitored expenditure submissions to appropriate grants. Interviewed, onboarded, trained and supervised, established goals, monitored performance and wrote performance evaluations for four Research Assistants. Approved and submitted monthly effort reports and timesheets. Wrote content for monthly newsletter.
University of Pennsylvania
Pulmonary Medicine Data Manager/Auditor (Term App’t), Philadelphia, PA (Aug, 2016-Sept, 2016)
Audited data quality of an elite Study investigating LAM. Created more than sixty case report forms to streamline and improve quality of data collection.
Maternal Fetal Medicine Research Coordinator (Full-Time), Philadelphia, PA (Jun, 2008-Dec, 2009)
Identified, recruited and consented patients to pre-term labor and pre-eclampsia studies. Performed phlebotomy, centrifuged and cryo-preserved peripheral and cord blood specimens; obtained DNA samples from neonates.
Obtained, processed and cryo-preserved placental biopsies.
Identified times for optimal recruitment opportunities to increase patient enrollment and changed my schedule to work off hours to increase patient enrollment.
Created source documentation capture sheets; researched electronic medical records for extensive data collection forms. Coordinated audits for sponsor-initiated study.
Anesthesiology and Critical Care Research Coordinator/Supervisor, Philadelphia, PA (July, 2007-June, 2008)
Created required regulatory submission documents for sponsor-initiated studies.
Created budgets; negotiated and wrote contracts with industry representatives.
Wrote and submitted IND application for use of GLP-1 peptide as a continuous infusion during surgery.
Trained and supervised four Research Assistants. Coordinated/prepared for sponsor audits. Monitored and ordered supply inventory and insured expenditures were charged to appropriate grant. Obtained Radiation Safety authorizations for Study equipment.
Department of Radiology Research Coordinator, Philadelphia, PA (Jan, 2006-July, 2007)
Created required regulatory submission documents work for nine Phase I oncology studies. Liaised with DoD for study testing effectiveness of 3.0 Tesla endo-rectal coil.
Recruited and consented study participants from Urology clinic. Resolved data queries from ACRIN and industry sponsors.
Coordinated Safety approval for study-related equipment. Audited two PET studies.
Department of Surgical Oncology Project Manager, Philadelphia, PA (Feb, 2004-Jan, 2006)
Coordinated on-site breast cancer production using autologous white blood cells with Apheresis, Elutriation, Microbiology and Vaccine Production Lab. Obtained quality assurance prior to vaccine administration.
Created/completed case report forms.
Wrote manual of operations, amendments to protocol, informed consent, IND application and continuing review submissions to IRB and FDA. Created recruitment signage and brochures and budgets for grant applications. Monitored and ordered study-related supplies. Maintained regulatory binders, study charts and Excel database of study subjects.
Family Practice and Community Medicine Research Assistant, Philadelphia, PA (Term App’t) (Feb, 2003-Jan, 2004)
Data mined and entered using Access for three large retrospective studies on the incidence of C-Section deliveries.
Wrote IND application for the use of prostaglandin gel off-label.
Researched funding opportunities. Contributed to grant applications. Processed incoming invoices for payment.
Contract Work
University of Pennsylvania Administrative Coordinator, Philadelphia, PA (Oct, 2002-Jan, 2003)
United Nations Classifications Assistant, New York, New York (Oct, 2001-Jan, 2002)
United Nations Special Events Assistant for UNICEF’s Special Session for Children, New York, New York (July-Sept, 2001)
Grey Worldwide Mediacom Administrative Assistant to Sr. Vice President (Oct, 2000-July, 2001)
MSNBC Researcher in the Broadcast Newsroom, Seacaucus, New Jersey (Sept-Oct, 2000)
Production Assistant, Steven Spielberg’s project, ‘Survivors of the Shoa.’ New York, New York (Jan-Dec, 1998)
Education
Columbia University School of General Studies
Certifications
Obtained COR, CITI, Phlebotomy and Interpreter for the Italian Language certifications.
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