Fatemeh Kouhzaei

***** ****** ****** **. ************, MD 20879 240-***-**** adoz4r@r.postjobfree.com

Experienced service support engineer with a demonstrated history in the pharmaceutical industry. Skilled in customer service, communication, and instrument management

Education:

Master of Science in Bioinformatics 12/2018

University of Maryland Global Campus

Bachelor of Science in Bioengineering 05/2016

University of Maryland, College Park, MD

Skills:

Pro-Engineer, R, Python, JAVA, Perl, Machine learning, Solid works, MATLAB, C++, Slicer, Microsoft Word, Excel, Power Point, AutoCAD, GMP, cGMP, HPLC, Next Generation Sequencing (NGS) analysis, CTRP, CT.GOV registration

Professional Licenses/ courses:

Packing and shipping division 6.2 materials training 08/2017, U.S. department of Health and Human Services

Blood borne pathogens training 08/2017, U.S. department of Health and Human Services

Data Management for Clinical Research 05/2021, Coursera

Work Experiences:

Leidos Biomedical Research Inc. (Clinical Data Analyst ) (11/19 – current)- Rockville, MD

NIH/NCI contractor

Review clinical trial documents for the National Cancer Institute (NCI) Clinical Trial Reporting Program (CTRP), and apply standards to create summary reports in accordance with Ethics and Human Subjects Protection guidelines.

Ensure data abstraction accuracy and consistency among team members while adhering to time expectations.

maintain clinical trial registries, such as ClinicalTrials.gov (CT.gov)

communicate with staff at CT.gov to address any automated notifications of FDAAA violations to determine the appropriate response

Effectively communicate with trial submitters to address requests/questions/concerns and clearly document actions taken.

Collaborate with application developers to perform user acceptance testing.

Contribute to process improvement initiatives, including revision of standard operating procedures.

Manage special requests and other duties in support of the Clinical Trial Reporting Program (CTRP).

Respond to inquiries and resolve issues submitted to an issue/ticketing system (e.g., ServiceNow) by the cancer research community and program stakeholders, utilizing effective communication

Provide end user training for new and existing cancer centers customers

Review documents, validate trial information, abstract relevant administrative data and perform quality control checks following standard guidelines/SOPs

Complete new trial and amendment registrations and acknowledge trial updates

Assist to improve Standard Operating Procedures and User Guides

Troubleshoot and appropriately report unexpected problems that may arise during the data abstraction of clinical trials

Participate in data clean-up related activities

Pulled accrual data from data Warehouse via PostgreSQL.

Used advanced Microsoft Excel and the XLOOKUP function to create pivot tables.

Generate tables, figures and listings in support of project presentations

Thermo Fisher Scientific- ULS (Senior Site Specialist) (10/2017 – 11/2019) Rockville, MD

As service support engineer for the Rockville, GlaxoSmithKline site, I established an organized inventory management system for all lab equipment. While responsible for maintaining, tracking, and effectively communicating status of lab instruments to the customer; I engaged external partners for service and maintenance. Effectively managing over 1,000 units of equipment in a BSL2 laboratory facility.

Develop quarterly business reviews, action plans, and tracking mechanisms to drive continuous improvement.

Increased overall customer satisfaction by using exceptional communication, and customer service skills.

Used communication and customer service soft skills to engage all stakeholders using system; setting up regular meetings and schedules for updates and changes.

Continuously meet Thermo Fisher’s and GSK’s service level agreements (SLA) while maintaining accurate standard operating procedures (SOP).

Develop key performance indicators to track the success of system management for objectives and deliverables within set procedures.

Responded to ongoing customer requirements in system delivery, altered or enhanced operating procedures to create a fit for purpose service environment.

Process customer requests for new equipment commissioning, decommissioning, and intra-site moves, within a laboratory environment.

Coordinate problem resolution with engineering, customer service, and other personnel to expedite repairs.

Provide a communication link between the customer and the company to help ensure that effective service is provided to the customer.

Coordinate maintenance, support, documentation, and testing activities to ensure compliance with specifications.

United States Pharmacopeial (Research Assistant, Intern) (4/2017- 8/2017 )- Rockville, MD

Perform literature searches using publicly available resources (FDA, DEA, International Health Agencies, etc.) to identify instances deserving inclusion.

Insert the information into the database with utmost attention to maintaining data integrity.

Conduct searches of supporting information (product images, relevant business records), and appending them to the database records.

Develop process strategies for the food fraud department.

Thermo Fisher Scientific (Production Technician) (9/2015- 2/2016 )- Fredrick, MD

Followed standard operation procedures to ensure compliance with customer specifications and cGMP’s.

Stage and weight of job components, initiate manufacturing paperwork, reconciliation of batches.

Perform filling, capping and labeling of finished goods.

Create manufacturing batch records.

Pull and print product inserts and labels according to master label specifications.

Children’s National Hospital, Intern (10/2014- 05/2015) – Washington DC

Worked as a part of a lab team to develop non-invasive treatment for pediatric medicine using MR-guided focused ultrasound

Designed a moving phantom that imitates breathing

General Research Lab, Inc: Intern (6/2013 – 8/2013) – Gaithersburg, MD

Worked as part of a lab team aiming to identify and test botanical drug products and their potential to enhance the efficacy of standard chemotherapeutic agents, while reducing toxicity and also performed experiments including Western Blot, PCR, RNA extraction

Projects during study:

Database Project (SQL) (05/2018- 12/2018) - University of Maryland University College

Created an ERD that illustrate logical structure of the database.

created an organized database design that was functional.

Created the final script in SQL

Senior Capstone Project (8/2014-5/2015)- University of Maryland

Department of Bioengineering

Collaborate with a team of doctors and undergraduates to develop 3D printed medical models.

Segment CT Scans into printable files through Mimics software.

Manage project from inception to completion.

Test material properties of 3D device through finite element analysis.

Engineering Design Project

Collaborated with students to develop and test an autonomous hovercraft controlled by an Arduino.

Produced 3D CAD model of hovercraft with Solidworks and constructed the hull.

Presented preliminary and final designs to a faculty board and finished with a 20 page report.

Biomechanical Analysis of Elbow injury

Calculated static and dynamic forces at elbow before, during and after throwing a baseball.

Produced results for modeling static analysis and dynamic analysis of elbow.

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