Summary
Overview
Work History
Education
Skills
Timeline
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Elaine Edwards

Durham,NC

Summary

Clinical Research Personnel

Versatile clinical research professional knowledgeable about compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities. Familiar with GCP (Good Clinical Practice). Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

Overview

30
30
years of professional experience

Work History

Clinical Research Project Management, Analyst II

ICONplc
05.2021 - Current
  • Member of the Strategic Partnership Integration & Solutions (SPIS) Department
  • Guide and assist in building partnerships by working with the Partnership Operational Leads and the Subject Matter Experts (SMEs)
  • Coordinate and facilitate the SMEs to write operational manuals, building collaborative spaces such as Box, and designing the FIRECREST portal (document management portal)
  • Skilled at working independently and collaboratively in a team environment.
  • Self-motivated, with a strong sense of personal responsibility.
  • Excellent communication skills, both verbal and written.
  • Results: Develop platforms and processes for partnerships to continue to work in a proficient manner
  • Proven ability to learn quickly and adapt to new situations.
  • Work well in a team setting, providing support and guidance.
  • Work effectively in fast-paced environments.
  • Manage time efficiently in order to complete all tasks within deadlines.
  • Demonstrate respect, friendliness and willingness to help wherever needed.
  • Strengthened communication skills through regular interactions with others.
  • Use critical thinking to break down problems, evaluate solutions and make decisions.
  • Identified issues, analyzed information and provided solutions to problems.
  • Participate in team projects, demonstrating an ability to work collaboratively and effectively.

Clinical Research Project Management Analyst I

ICONplc
11.2020 - 05.2021
  • Assisted the operational staff in the development and implementation of departmental process improvements
  • Assisted with monitoring assessment of quality metrics and/or key quality indicators
  • Assisted project teams with quality control processes under the direction of CQC Senior Specialists or Leads
  • Scheduled and managed internal and external meetings, assisted in the production of presentation materials
  • Contacted external and internal customers to collate relevant study information for overall end-to-end management of quality events
  • Prepared and issued internal department reports.

In-House Clinical Research Associate

ICONplc
08.2015 - 11.2020
  • Reviewed clinical data
  • Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
  • Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
  • Collected regulatory documents and ensured accuracy, audit ready filing in the electronic trial master file
  • Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
  • Implemented electronic data capturing systems to adhere with clinical research guidelines.
  • Submitted routine reports and follow-up letters to facilitate internal and external communication.
  • Liaised with clinical project leader to effectively resolve study-related issues.
  • Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies.
  • Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding.
  • Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
  • Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
  • Liaised with site department personnel to communicate important clinical data and events.
  • Leveraged Data Management, Clinical Research Associate, and Project Management knowledge, expertise and problem-solving techniques to resolve investigative site issues.
  • Performed data entry including protocol deviations, tracked contact with sites, and performed regulator reconciliations
  • Provided support to the traveling Clinical Research Associates (CRA) team.

Clinical Trial Assistant

ICONplc
04.2014 - 08.2015
  • Provided support in managing the Investigator and Trial Master File
  • Also, provided support to the Clinical Research Associates (CRA) team
  • Archived and organized clinical investigator and trial master file documents, included clinical study site documents, email correspondence, training materials, and other study documents
  • Maintained internal tracker that consisted of correspondence and site documentation
  • Participated in the management of ICON’s clinical investigator and trial master filing structure; created physical and electronic filing structures; printed, prepared, filed, archived, and tracked paper and electronic documents according to the master file structure.

Senior Administrative Assistant

Daiichi Sankyo, Inc.
06.2010 - 02.2013
  • Provided advanced assistance to the Oncology and Thrombosis teams in Marketing
  • Performed various complex administrative support functions, included but not limited to, coordinating the interview process for open positions within the department and performed duties to ensure efficient office operations and stellar support to the Executive Directors and Directors.

Administrative Assistant/Clinical Research Coordinator

Corporate Brokers
04.2009 - 03.2010
  • Provided administrative support to the Clinical Operations team in Medical Affairs
  • Results: Assisted Clinical Research Associates (CRA’s) with reviewing data listings
  • Initiated department contract requests
  • Assisted with preparing for non-CME grant requests
  • Attended project team and department meetings, prepare and distribute minutes
  • Tracked Clinical Study Agreements.

Clinical Project Associate

Encysive Pharmaceuticals
03.2006 - 12.2008
  • Participated as a member of the Clinical Project and Project Management Teams
  • Processed all protocol exemptions, regulatory documents and site supplies
  • Tracked essential regulatory documents
  • Attended project team meetings and prepared and distributed minutes
  • Provided feedback to study leadership about protocol deviations and compliance with Standard
  • Conducted periodic regulatory study file audits.

Senior Administrative Assistant

Encysive Pharmaceuticals
03.2006 - 12.2008
  • Provided administrative support to the Clinical Development Department
  • Arranged travel for conferences and meetings, tracked department invoices, prepared and submitted expense reports for Clinical Team
  • Developed and managed tracking system for departmental Standard Operating Procedures (SOP’s) and ensured team members completed the required training for each SOP in order to meet company guidelines
  • Established and communicated expected action items from department meetings to assist staff members in achieving their goals.

Office Manager

Malesardi, Quackenbush, Swift & Company, LLC
09.2002 - 09.2005
  • Controlled the daily operations of the office by interviewing, hiring, and supervising the administrative staff of two
  • Addressed personnel issues as they occurred according to company guidelines and procedures
  • Monitored employee vacation schedules and responsible for instituting new time off policy
  • Served as point of contact for billing and client inquiries
  • Performed as time and medical health benefits administrator for all employees
  • Operated as point of contact for Human Resource inquiries and responsible for managing bi-monthly payroll
  • Arranged travel for conferences, meetings and assist with new projects
  • Made daily bank deposits and reconciled all accounts on a daily and monthly basis using QuickBooks
  • Prepared and entered invoices for multiple vendor accounts using ProFx Practice Billing Software
  • Provided administrative support to partners and accounting staff using WordPerfect, Word, and Excel
  • Prepared computed tax returns using ProFx Practice Tax software
  • Executed professional financial statements according to company policy and guidelines
  • Maintained client accounts (light bookkeeping) using Libra Accounting software
  • Maintained pertinent files and personnel files on share drives and filed all paper documents accordingly.
  • Oversaw office inventory activities by ordering and requisitions and stocking and shipment receiving.
  • Updated reports, managed accounts, and generated reports for company database.
  • Managed office operations while scheduling appointments for department managers.
  • Coached new hires on company processes while managing employees to achieve maximum production.
  • Reported to senior management on organizational performance and progress toward goals.
  • Improved staffing during busy periods by creating employee schedules and monitoring call-outs.

Project Coordinator, Clinical Product Management

Merck-Medco, LLC
05.1994 - 04.2002
  • Coordinated and scheduled departmental and cross-functional meetings required for training preparation and material development
  • Also, supported the groundwork of presentations to guarantee all training material was in line with the course agenda
  • Served as point of contact for general requests relating to training and sales support materials, through maintaining files on a share drive to make materials easily accessible
  • Assisted the Account Management’s Training Coordinator to coordinate, track, and fulfill training deliverables
  • Collected all training evaluations that allowed the Program Managers to develop a process for tracking and updating all Sales Collateral inventory and to maintain a repository.

Senior Administrative Assistant

Merck-Medco, LLC
05.1994 - 04.2002
  • Provided administrative support to VP of Operations, VP of Medical Policies and Programs and several Directors
  • Maintained calendars
  • Scheduled luncheons and appointment for tours
  • Arranged travel for conferences and meetings
  • Prepared communication notices to employees from the VP of Operations
  • Prepared, submitted, and tracked departmental expense reports against travel schedules
  • Scheduled departmental and project meetings
  • Prepared department meeting minutes and tracked action items
  • Filing as needed, answering phones, taking messages.

Education

Masters of Science in Leadership -

Grand Canyon University

Bachelor of Science in Applied Management -

Grand Canyon University

Associates in Applied Science in Liberal Arts -

Katharine Gibbs School
Montclair, NJ
12.2019

Skills

  • Office Management
  • Corporate Communications
  • Relationship Building
  • Visio
  • Report/Document Preparation
  • Excel
  • MS Office
  • Meeting & Event Planning
  • Electronic Data Capture
  • Clinical Trial Management Systems
  • Task Prioritization
  • Emotional Intelligence
  • Conflict Resolution
  • Meeting Facilitation
  • Decision Making
  • Cross-functional Collaboration
  • Adaptability
  • Change Management
  • Document Management
  • Procedure Development
  • Client Relations

Timeline

Clinical Research Project Management, Analyst II

ICONplc
05.2021 - Current

Clinical Research Project Management Analyst I

ICONplc
11.2020 - 05.2021

In-House Clinical Research Associate

ICONplc
08.2015 - 11.2020

Clinical Trial Assistant

ICONplc
04.2014 - 08.2015

Senior Administrative Assistant

Daiichi Sankyo, Inc.
06.2010 - 02.2013

Administrative Assistant/Clinical Research Coordinator

Corporate Brokers
04.2009 - 03.2010

Clinical Project Associate

Encysive Pharmaceuticals
03.2006 - 12.2008

Senior Administrative Assistant

Encysive Pharmaceuticals
03.2006 - 12.2008

Office Manager

Malesardi, Quackenbush, Swift & Company, LLC
09.2002 - 09.2005

Project Coordinator, Clinical Product Management

Merck-Medco, LLC
05.1994 - 04.2002

Senior Administrative Assistant

Merck-Medco, LLC
05.1994 - 04.2002

Masters of Science in Leadership -

Grand Canyon University

Bachelor of Science in Applied Management -

Grand Canyon University

Associates in Applied Science in Liberal Arts -

Katharine Gibbs School

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Elaine Edwards