Clinical Research Quality Assurance
Resume:
Yelena Dmitriyeva
Brooklyn, NY, 11224
Telephone: 646-***-**** Email: ****************@*****.***
Summary:
Experienced in Clinical Project Management
•
Therapeutic Areas: Oncology, Metabolic, Respiratory, Anti Infective, HIV/AIDs,
•
Dermatology, Gastroenterology
Experienced in FDA audits and GCP/ICH guidelines
•
Proven track record of organizational, communication, interpersonal, and multi
•
tasking skills
Education
Masters of Science in Business Management
Kaplan University
Area of Specialization: Healthcare Management
Bachelors of Arts degree with honors
Brooklyn College, City University of New York (CUNY)
Major: Biology Minor: Chemistry
Clinical Research Associate Certification
Kriger Research Center
Clinical Research Associate Program
Employment
1/14 – current Clinical Research Coordinator Clinical Research Center of CT
• Responsible for the overall coordination, organization, communication, and efficient
implementation of clinical trials.
• Performs subject screening, evaluation, data collection and follow up through study
completion.
• Perform diverse clinical, administrative, and clerical responsibilities requiring
competent analysis, judgment, and detailed understanding of specific study protocols.
• Complete all study related procedures, educates and guides subject participation in
regard to recruitment and compliance under the direction of the Principal Investigator
and Medical Director.
• Creates and maintains accurate, confidential files and documentation of study
subjects, as per HIPAA guidelines.
3/13 – 12/14 Research Coordinator Day Dermatology & Aesthetics
• Manage day to day clinical research operations
• Assist with study start up, maintenance, and close out
• Ensure study regulatory compliance and integrity
• Oversee patient enrollment, randomization and follow up
• Maintain patient scheduling and communication
• Manage study budget, including billing and payments
• Maintain and order study equipment and supplies
• Create and maintain study documents and reports
• Communicate with IRB to obtain timely approvals
• Function as a liaison between research investigator, study sponsor and monitors
• Collect patient information and maintain study database
• Perform data quality assurance and resolve queries
• Use Electronic Data Capture system
2/11 – 11/12 Data Control Coordinator Weill Cornell Medical College
• Assist with federal and industry sponsor clinical trial submissions
• Maintain records and assist in keeping track of grant budgets, submissions and
approvals
• Create project regulatory documents such Informed Consent, information sheets,
HIPAA
• Prepare all IRB documents and maintain correspondence with sponsoring company
and IRB
• Work with study sponsor and monitors to oversee clinical trial data completeness and
integrity
• Prepare project Billing Analysis Forms for billing compliance and quality assurance
• Utilize Patient Protocol Management system for clinical trial submission process
• Maintain database of study participants and contact study participants
• Review patient history and records
• Attend to laboratory procedures for specimen processing and shipment
7/07 – 11/10 Clinical Trials Associate Execupharm, Inc. (at Pfizer, Inc.)
• Quality assurance, submission, and archiving of regulatory and clinical documents
• Assisting with study protocol and informed consent documents development and
revisions
• Managing all project documents in several databases and repositories
• Statistical data analysis of Oracle Clinical remote data capture system
Finance management in Pegasus, ARIBA, Computron, and GCE.
•
Maintenance and updates of Right Track trial management system
•
Collection, translation, and delivery of medical reports for the Data Review Committee
•
Collection, review and submission of laboratory documents from sites
•
Review and presentation of study related information for study managers
•
Collaboration of project work with other functional lines within the project
•
Ordering and distribution of clinical supplies to research sites
•
Creation and distribution of project newsletter
•
Creation and distribution of weekly study updates for clinical investigators and
•
research
site managers
9/06 – 7/07 Administrative Assistant Pfizer, Inc.
• Quality assurance of documents for submission and archiving in Trial Master Files
• Maintain and update database systems
• Process project invoices via Pegasus and ARIBA
• Assist with collection and retrieval of Investigator Initiation Packages
• Manage all CRO correspondence and mailing
• Coordinate and ship clinical supplies and documents to clinical investigators
• Create and maintain data spreadsheets
• PowerPoint presentation preparation
• Manage calendars, meetings, and travel
• Filing, faxing, and word processing
Contact this candidate