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Clinical Research Data Entry or anything Home based

Location:
Fort Myers, FL
Posted:
March 21, 2019

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Resume:

Deanna M. Buonomo

** ****** ***. ********, ** ***52 617-***-**** ac8uv2@r.postjobfree.com

SKILLS & STRENGTHS

Extremely organized, attentive, and thrive in a fast-paced setting

Excellent leadership, communication, and interpersonal skills

Strong work ethic, ambitious, and a charismatic personality

Able to build credible relationships and work in a team environment as well as independently

Highly capable at multitasking and problem solving with keen attention to detail.

Previous training in HIPAA, GCP and FDA/ICH guidelines, CITI, OSHA, BBP, Hazardous Waste, Radiation Safety Awareness, CPR, IATA, Dry Ice, etc.

Familiarity with many EDC systems including, but not limited to: Medrio, iPortal, eCRF online, Epi Info 7, and Viedoc.

Windows and Mac proficient; Excel, PowerPoint, Word, Outlook etc.

WORK EXPERIENCE

Clinical Research Coordinator at Massachusetts Eye & Ear Infirmary APR 2018 – SEP 2018

Ophthalmology Research (Contract Position)

-Coordinate research studies with a main focus in Neuro-Ophthalmology, Ocular Melanoma, and Retinal Diseases.

-Plan and organize study initiation, screen and recruit patients for clinical studies according to the study protocol criteria, and ongoing data collection activities for the assigned clinical trial or clinical research study in Ophthalmology. May develop study Standard Operating Procedure from approved Human Study Protocol.

-Coordinate and communicate with the Principle Investigator leading the study as appropriate with input from the research supervisor and assist in the writing of clinical study protocols for review by the Human Studies Committee with input from the supervisor or Study PI.

-Execute multiple clinical studies for a variety of Ophthalmology Investigators and work with the clinical trials administration team to assist with study financial management and coordinate advertising for clinical studies.

-Provide patients with information and answering questions regarding these studies.

-Ensure protocol is being followed and making sure all the personnel’s involved in the study is trained per protocol requirements.

-Set up patients follow up appointment and coordinating with physicians/departments.

-Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries.

-Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations whenever required.

-Responsible for organizing and preparing for both internal and external auditing and study monitoring visits and making sure all required training both for CITI and MEEI training requirements are up to date. Also, responsible for all in-house monitoring of Regulatory binders as well as all patient binders prior to sponsor/CRO monitor visit.

-Participate in appropriate training for each study including, standardization and/or certification to perform study procedures and serve as a liaison between corporate study sponsors and the MEEI Service Department.

-In the absence of the Investigator, may represent the site at Investigators' Meetings for new and/or ongoing clinical trials with the clinical research supervisor.

-Responsible for adherence to DHHS guidelines, including maintaining required regulatory documents, submitting adverse event reports, annual reviews, and other required reports to the IRB, study sponsor, and other agencies as necessary.

Clinical Research Coordinator at Tufts University School of Dental Medicine OCT 2015 – APR 2018

Oral Medicine Research

-Coordinated research studies with a main focus in Oral Medicine and auto-immune diseases relating to the oral cavity (i.e. Sjogren’s Syndrome) with Responsibilities including: ensuring studies are run in accordance with protocol and GCP/FDA standards, conducting the informed consent process, training new coordinators, writing, editing, and submitting all research documents, as well as maintaining proper regulatory files and research databases.

-Aided in all site start-up activities including IRB submissions, creating/amending protocols and ICFs to conform to standard guidelines, and meet with study sponsors for SIVs.

-Developed, review and maintain all essential documents, Informed Consent Forms, and Case Report Forms.

-Managed all aspects of IRB submission including initial protocol/ICF/IB approval, site-specific documents, and protocol amendments and maintains and tracks revisions to all documentation for accuracy

-Assured sterile research facilities, recruiting, screening, and scheduling subjects, conducting a comprehensive review and analysis of statistical data, monitor CRFs to be sure all are inputted correctly, input all data entry.

-Communicated with Monitors and sites, track delivery and receipt of study product and/or bio specimens, review monitoring reports after post-study visit.

-Understood Standard Operating Procedures, GCP standards, US Federal Food and Drug Administration and local regulations including Pre-study, Site Initiation, Routine Monitoring, and Close-out Visits.

-Responsible for all in-house monitoring of Regulatory binders as well as all patient binders prior to sponsor/CRO monitor visit.

Clinical Consultant at ViaCord by PerkinElmer JUN 2013 – APR 2014

-Learned and absorbed a large amount of knowledge on the usage of newborn stem cells as regenerative medicine.

-Educated expecting parents on newborn stem cell preservation and genetic screening services.

-Motivated prospective clients from inquiry to enrollment while emphasizing quality, value, and results over price.

-Managed and maintained a detailed pipeline to achieve daily, weekly, and monthly sales goals.

Pharmacy Technician at Rite Aid Pharmacy AUG 2010 – JUN 2013

-Assisted pharmacists in the development of and quality control of prescription medications.

-Monitored incoming communications—answered phones, accepted prescription orders from various physicians’ offices.

-Managed new clients’ prescription recording in the drug interaction database while abiding by all HIPAA regulations.

-Advised customers on the selection of medical brands, equipment, and healthcare supplies.

EDUCATION

Massachusetts College of Pharmacy and Health Sciences

BS Pharmaceutical and Healthcare Business

ABSTRACTS & PRESENTATIONS

E. Tzavaras, P. Corrado, D. Buonomo, J. Cimmino, M. L. Singh, S. Pagni, A. S. Papas. Comparing OSDI and FACIT in a Xerostomic Population. IADR 2017 San Francisco, CA.

A. Bugshan, A. Farag, N. Kafasis, D. Buonomo, A.S. Papas, M.L. Singh. Evaluation of Dental Status and Tooth Surface Loss In Xerostomics. IADR 2018 Fort Lauderdale, FL.



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