natasha_battle curriculum vitae final revision

Natasha Battle124 Wesley Drive

Norlina, NC 27563(252) 204-2042

JOB TITLE: Clinical Monitoring Associate

SUMMARY OF EXPERIENCE:Clinical Monitoring Professional with a total of 10 years of industry experience working with large and mid-sized Sponsors including GSK and Pfizer in national and global phase IV/III studies. Significant knowledge working in Pharmacovigilance as a Safety Data Specialist in addition to Project Coordination, prior to joining PAREXEL. Since joining PARXEL, primary responsibilities include remote site monitoring and management, applying expertise and independent judgment for designated projects in accordance with relevant regulations, SOPs, and study specific guidelines ensuring patient safety and data integrity at all times. Act as PAREXEL’s remote contact with assigned clinical sites. This includes managing/supporting site activities remotely, resolving site issues, and ensuring timely/high quality data entry at a site level.

THERAPEUTIC AREA EXPERTISE: Adult Asthma Pediatric Asthma Diabetes type II Psoriasis Lupus Bi-polar disorder Osteoporosis

PROFESSIONAL EXPERIENCE:Clinical Monitoring Associate, PAREXEL International, Durham, NC, United StatesMarch 2014-Present

Co-monitor onsite interim monitoring visits Conduct remote visits (qualification, initiation, monitoring, and termination) as needed using CTMS and

eDC study systems. Prepare sites and CRAs for on-site visits Act as PAREXEL’s remote contact with 32 assigned clinical sites, use judgment to assess and ensure

overall integrity of study implementation and adherence to study protocol at clinical sites Prepare and collect high quality site documents, such as essential regulatory documents Collaborate and involve Clinical Trial Specialists (CTS) on CSA (including budget) and site specific ICF

negotiations as required Collaborate with CTS and CRA on site issues/actions and provide recommendations regarding site-

specific actions and use judgment and experience to assess the ability and motivation of site staff. Observe/recognize trends and training deficiencies in site staff and re-train them on study specific

tasks/procedures remotely as required

CV Version Date: 09 June2015Natasha Battle

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Norlina, NC 27563(252) 204-2042

Ensure timely resolution and closure of all site issues (including Central File QC findings). Escalate any site and study issues that require immediate action to the PL Build relationship with investigators and site staff remotely Generate contact reports in accordance with departmental timelines and/or sponsor timelines whichever

is shorter Attend study Investigator meetings

Research Operations Assistant, PAREXEL International, Durham, NC, United StatesJune 2012 – March 2014 Track, scan, code, photocopy, and file study documents for the Trial Master File Prepare, distribute, store and archive study files, as applicable Assist with technical preparation of audits Support preparation of study-specific documents Manage the distribution study documents and supplies to sites (e.g. courier shipments) Assist with the technical organization of translations of study document Assist with the collection of study level signatures within PAREXEL, as applicable Assist with the organization of internal and external meetings/trainings Assist Global Research Operations (GRO) team members and investigators (if required) with travel

arrangements Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory

requirements and PAREXEL SOP and stud specific procedure Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, meeting minutes, and

travel expense claims) As required, maintain technical and office equipment (Copy machines, printers, etc.) in cooperation with local

IT/Facilities As required, order office supplies and maintain stock levels

Safety Data Specialist, Cato Research Ltd. Durham, North Carolina, United StatesSeptember 2008 – June 2012 Update all sponsor Lotus Notes mailboxes and folders as needed Assist with daily receipt of serious adverse event (SAE) faxes for both initial and follow-up reports File, print, log, and send acknowledgements of receipt to the sites, and for notifying the sponsor and team

members of the SAEs to project teams and sponsors Responsible for data entry of SAE report information into the designated safety database according to

written sponsor specific guidelines Responsible for the compilation into a follow-up report of inconsistencies or missing data found during the

case entry Assist with the organization of the file room, the creation of case files and case activity sheets

Senior Project Support Assistant, Cato Research Ltd.June 2005 – September 2008 Project filing, word processing, photo copying, mass faxes and mass Fed Ex mailings


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Norlina, NC 27563(252) 204-2042

Assist with creating mail merges for mass mailings Assist with randomizations for blinded studies Maintain electronic fax server Assist with compiling clinical site binders, notebooks and training material Provided training on the roles and responsibilities of Project Support Assistants and faxes during new

employee orientation and Project Coordinator Training Participated in interview panels for potential candidates in the Project Coordination group

Customer Service Specialist, Fidelity Investments, Raleigh, NC, United StatesOctober 2004 – June 2005 Worked in the Defined Benefits Department, supporting the General Motors account in pensions Responsibilities included updating accounts for in-pay clients.

Sales Audit Clerk, Variety Wholesalers, Henderson, NC, United StatesFebruary 2000 – October 2004 Assist with balancing cash reports for Super 10 and Roses Stores Worked with office managers to ensure that each cash report balanced correctly. Entered data into the

computer using AS/400 and Microsoft Excel

Receptionist/Secretary, Child Development Corp., Littleton, NC, United States1999 – February 2000Performed various clerical duties such as filing, answering the phone, and typing business correspondence for the daycare facility

EDUCATION:2014: Site Manager Basic Training, Durham, North Carolina

2011: Project Training; Cato Research Durham, North Carolina

2002: Office Systems Technology Vance-Granville Community College Henderson, North Carolina, United States


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natasha_battle curriculum vitae final revision

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