Summary
Overview
Work History
Education
Skills
Work Availability
Quote
Timeline
AccountManager
Anisha Washington

Anisha Washington

Lake Hiawatha,United States

Summary

Organized and motivated skilled professional with many years of pharmaceutical experience, eager to apply time management and organizational skills in various environments. Interact effectively with individuals at all levels and capable of handling demanding tasks in team situations. Many positions have required working under difficult deadline pressures in fast-paced environments, thinking quickly, and resolving problems independently. Possession of solid oral and written communication abilities coupled with software applications experience, including Documentum, Adobe Acrobat, ISI Toolbox, and various Microsoft Office programs including but not limited to MS Teams. Always interested in expanding my skills and knowledge to advance my career.

Overview

16
16
years of professional experience

Work History

Virtual Elementary School Teacher and Substitute

Various Employers
09.2015 - Current
  • Maintaining an elementary teacher position while actively seeking a Clinical Trial Coordinator role in the pharmaceutical industry.

Clinical Support Coordinator

Bayer Pharmaceuticals
Whippany, NJ
07.2012 - 11.2013
  • Setup and maintained trial units in IMPACT; administered reports in Business Objects; track patient queries utilizing RaveTrack.
  • Participant in mock audits and process improvement; prepared study start-up packets and regulatory bins for distribution to sites; process of CDAs, feasibility questionnaires, and tracking of Regulatory documents; accessed budget needs for study start-up and new Trial Investigators.
  • Executed daily support functions for Study and Clinical Lead Monitors; produced study team meeting minutes; uploaded all clinical study documents in SharePoint including CSR appendices.

Compliance Specialist, Research and Development

Research Pharmaceutical Services
Bridgewater, NJ
06.2011 - 05.2012
  • Quality checked essential site-specific study start-up regulatory documents for completeness and accuracy. Logged, scanned, organized, maintained and archived files per required processes; ensured timelines, orderliness, and the safekeeping of documents throughout the lifecycle of each study for USMA and R&D for all therapeutic areas.
  • Conducted rigorous file review in support of internal and external audits; identifying and addressing all file inconsistencies, taking corrective action.
  • Utilized ISI Toolbox to scan, compile, clean and bookmarked regulatory documents.

Clinical Trials Assistant

Forest Research Institute
Jersey City, NJ
04.2010 - 06.2011
  • Reviewed and tracked trip reports utilizing CORE and FOCUS; ensured all trip reports were received and completed properly by assigned RSM; essential documentation was received and appropriately filed within the TMF.
  • Performed in-house CRA responsibilities, managed regulatory documentation (i.e.1572s, CVs, Medical Licenses, Financial Disclosures, ICFs, and signature pages) completed by clinical sites, including IRB documentation from Local IRBs for both US and Canada utilized tracking tools such as MS Access and MS Excel.
  • Coordinated and maintained communication with clinical team and legal department for negotiation and distribution process of clinical trial agreements for initiation of clinical trials. Resolved site inquiries; assured accuracy of final agreements and tracked records within each study.

Clinical Trials Coordinator

Sanofi-Aventis Pharmaceuticals
Bridgewater, NJ
06.2007 - 03.2010
  • Maintained familiarity with FDA regulations and ICH and GCP guidelines to contribute to process improvement efforts by assisting in development of SOPs and Work Instructions, participating in various pilots within Medical Operations to enhance productivity and correct inefficient business practices according to FDA regulations.
  • Corresponded with investigative sites as necessary, including ordering study drug, setting up Investigator meetings, and providing archiving direction for legacy studies.
  • Juggled multiple projects and tasks to ensure high quality and timely delivery.
  • Improved operations by working with team members to find workable solutions.
  • Provided scientific and logistical support to Clinical Trial Managers (CTM) under the direction of Director with study start-up, review of regulatory documents, track investigator feasibility questionnaires, request CDAs, CSAs from Legal; update CTMS systems such as Profile, IMPACT, Clubnet with current site information and key dates for planned and ongoing trials;
  • Prepared, gathered, and imported clinical appendices for CSRs including cleaning hyperlinks, bookmarks ensuring accuracy of published report in Documentum and Core Dossier according to SOP and FDA standards in preparation for submission.
  • Generated SAP reports for various budget needs; liaison between Purchasing, Finance, and Accounts Payable departments; creating Purchase Orders for new and existing projects; reconciling, tracking payments to CRO, and Investigative sites utilizing financial systems such as eCaf, APPS, SAP, and Ariba; provided financial training to CTM and CTC staff.

Education

Associate of Science - Business Administration

County College of Morris
Randolph Township, NJ
06.2010

Business Management

Thomas Edison State University
Trenton, NJ

Skills

  • Organizational Skills
  • Good Work Ethic
  • Planning & Organizing
  • Microsoft Office
  • Critical Thinking
  • Training & Development
  • Problem Resolution
  • Computer Skills

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote

The way to get started is to quit talking and begin doing.
Walt Disney

Timeline

Virtual Elementary School Teacher and Substitute

Various Employers
09.2015 - Current

Clinical Support Coordinator

Bayer Pharmaceuticals
07.2012 - 11.2013

Compliance Specialist, Research and Development

Research Pharmaceutical Services
06.2011 - 05.2012

Clinical Trials Assistant

Forest Research Institute
04.2010 - 06.2011

Clinical Trials Coordinator

Sanofi-Aventis Pharmaceuticals
06.2007 - 03.2010

Associate of Science - Business Administration

County College of Morris

Business Management

Thomas Edison State University
Anisha Washington