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Clinical research associate/ clinical data manager

Location:
Raleigh, NC
Posted:
March 06, 2018

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Resume:

Julia Mazin

ac4pr0@r.postjobfree.com

Mobile: 440-***-****

Objective:

Highly motivated and organized individual looking for a full-time position. Fast learner, quickly incorporates and implement new procedures, solid work ethic in delivering high-quality service to customers. I function well, as both independently and as a team member, high self-motivated, with ample customer service experience. Available for full-time career opportunities immediately.

Education:

Bachelor of Health Services Management – University of Maryland, December 2018

Associate of Science Chemistry and Biochemistry -- Montgomery College, December 2015

Software Testing and Quality Assurance (QA) -- Montgomery College, June 2015

Programming Fundamentals -- Montgomery College, May 2015

Pharmacy Technology Certification Program -- Cuyahoga County Community College August 2011

Bachelor of Production Processes of Food Products for Public Catering -- South Ural State University 2005

Technical knowledge:

Software Experience: C3D, Inform, JReview, Rave, Microsoft Office, Excel, Outlook, MedConnect, Pyxis, Med Carousel, Clean Room, Simplify 797, VeriForm

Professional Experience:

Peraton/National Cancer Institute, MD Clinical Data Manager 3 June 2017 to Present

•Review trial-related documents including but not limited to Informed Consent Forms (ICF), source documents, patient instruction guides, and Case Report Forms (CRFs)

•Monitor progress of clinical trials by developing progress reports for the Investigator (e.g., patient accrual, audit reports and findings, data transmission and data reporting activities, etc

•Independently perform project specific quality control and quality assurance tasks on all projects responsible for as well as when requested

•Contribute to the design of the databases and forms, ensuring they meet requirements for the entry and reporting of clinical data of varying complexity

•Manage the delivery of high quality data from project start-up and planning to project execution and project closeout on several projects

•Ensure consistency, accuracy, and adherence to federal regulations, Good Clinical Practice, Good Clinical Data Management Practices, as well as SOPs and Working Instructions

•Manage patient protocol information and review protocol and incorporate protocol-specific guidelines into the review of clinical trial data on several projects simultaneously

•Test new processes and systems for the management of data in clinical trials.

•Test clinical trial databases and data entry screens assuring compliance with protocol and institutional processes and procedures.

•Process, track, and validate data accurately and on time, in accordance with data processing and entry instructions

•Perform data abstraction and data entry on several different protocols into multiple clinical research databases

•Develop and extract patient clinical data reports for publications and presentations

•Possess proficiency with clinical databases and report tools

•Identify project specific reports and assist in the development of these reports

•Prepare, review, and submit clinical data to monitoring agencies.

•Maintain client communication regarding data management project status and review key project questions with clients

•Communicate project status and key project issues to management

•Perform other duties as directed by CDM Supervisor, and research team

Harris Corporation/National Cancer Institute, MD Clinical Data Manager 2 January 2015-June 2017

•Manage the delivery of high quality data from project start-up and planning to project execution and project closeout on several projects

•Ensure consistency, accuracy, and adherence to federal regulations, Good Clinical Practice, Good Clinical Data Management Practices, as well as SOPs and Working Instructions

•Manage patient protocol information and review protocol and incorporate protocol-specific guidelines into the review of clinical trial data on several projects simultaneously

•Test new processes and systems for the management of data in clinical trials.

•Test clinical trial databases and data entry screens assuring compliance with protocol and institutional processes and procedures.

•Process, track, and validate data accurately and on time, in accordance with data processing and entry instructions

•Perform data abstraction and data entry on several different protocols into multiple clinical research databases

•Develop and extract patient clinical data reports for publications and presentations

•Possess proficiency with clinical databases and report tools

•Identify project specific reports and assist in the development of these reports

•Prepare, review, and submit clinical data to monitoring agencies.

•Maintain client communication regarding data management project status and review key project questions with clients

•Communicate project status and key project issues to management

•Perform other duties as directed by CDM Supervisor, and research team

MedStar Washington Hospital Center, DC Pharmacy Technician June 2014 to January 2015

•Work closely with pharmacist and use medication input software to safely and accurately dispense medication.

•Accurately pull medications from the shelves for Pyxis replenishment and deliver them to the various patient care areas to ensure proper levels are maintained.

•Maintaining a clean work environment on a daily basis

•Re-stocking the hospital’s Pyxis machines

St. Vincent Charity Hospital, OH Pharmacy Technician June 2011 to May 2014

•Checking inventory levels to assure adequate supply levels

•Organizing pharmacy supplies on shelves

•Compound IVs in the Pharmacy clean room

•Maintaining a clean work environment on a daily basis

•Filling unit dose orders via Med Carousel

•Re-stocking the hospital’s Pyxis machines

•Checking Med Carousel for expired medications



Contact this candidate