Project Manager High School
Resume:
Phyllis Hedgepeth
Durham, NC 27707
**********@*****.***
PROFESSIONAL SYNOPSIS:
Professionally qualified with over 20 years experience of visable achievements in many aspects of the
clinical research arena. Team player dedicated to quality and continuous improvement.
SUMMARY OF QUALIFICATIONS:
• Knowledgeable in local and central IRB submissions
• Demonstrated competency in monitoring processes, medical coding and regulatory document
collection
• Demonstrated use of Excel, Word, PowerPoint, Office, eRoom Regulatory Document Database,
Peoplesoft Tracking System, Express/UPS Shipping Software
• Outstanding interpersonal skills; equally comfortable communicating one-on-one
EMPLOYMENT
PPD
Research Triangle Park,, NC
Site Intelligence & Activation
Feb 2014 – Jun 2014
• Created templates for regulatory documents specific to local and central IRB submissions
• Collected and reviewed site regulatory documents.
• Updated company databases with document collection and all communication made with site
during start-up phase.
• Reviewed and drafted final ICF for submission.
• Attended operation meetings, training initiatives and project team meetings.
• Responsible for distributing Clinical Trial Agreement and Budget confirmations to site.
BioMerieux (Contractor)
Durham, NC
Quality Assurance Specialist
Nov 2012 - Apr 2013
• Responsible for proof-reading, editing documents to ensure internal consistency with Company
SOPs, FDA, GCP regulations and ICH guidelines.
• Responsible for cross checking internal consistency of text between sections and verification of
relevant text against tables, figures and data listings.
• Generated a clearly written QC report documenting all findings following each QC document
review, and within the required timeframes.
• Maintained and reported relevant performance and compliance metrics.
• Identified and provided resolutions of documentation errors
• Corrected calculations of gross/tare/net weight.
• Reconciled issues with respect to timed and effective review of release batch records.
PRA International
Raleigh, NC, NC
In-House CRA 2
Jan 2012 - Sept 2012
• Performed essential document collection & review.
• Ensured accuracy & completeness of paper and/or electronic trial master file documents
submitted during start-up.
• Performed QC review of files before transfer to Maintenance for filing in TMF.
• Served as the primary point of contact for the Project Manager, Regulatory Lead (or designee)
during startup on allocated projects.
• Prepared & submitted Central EC/IRB Applications, Local EC Applications, RA Applications, &
other local regulatory authorities or hospital approval submissions as required.
• Collected information on submission deadlines & timeline metrics for Regulatory Authority,
Ethics Committees, Investigational Review Boards & other local bodies as appropriate.
• Provided quality review of the informed consent prior to submission to IRB.
Novella Clinical Research
Research Triangle Park, NC, NC
Document Control Coordinator
Apr 2008 - Dec 2011
• Managed Clinical Document Control files room for all Novella Clinical studies, paper and
electronic.
• Responsible for entering site information into TMF utilizing scanner and copier.
• Provided guidance on document /report preparation and content.
• Ensured that the content and format complied with company/sponsor guidelines.
• Assisted in preparation of audit plans and checklist against applicable standard.
• Received and inventoried clinical documents and clinical files as well as project specific
regulatory documents.
• Supervised contract / permanent employees.
• Assisted QA doing Sponsor Audits and Regulatory Inspection.
ICON Clinical Research
Research Triangle, NC, NC
Project Assistant
Aug 2007 - Mar 2008
• Responsible for set up and maintenance of newsletter and study documents
• Tracked and ordered study supplies.
• Assembled and distributed study materials weekly.
• Updated monthly status report.
• Assisted with investigator meetings - prepared invitation mailings, tracked responses, made
travel arrangements and assembled meeting materials.
• Assisted with training of new personnel.
• Investigated incomplete, inaccurate or missing documents to ensure accuracy and completeness
of data.
• Maintained communication with sites to provide information, track documentation.
• Responded to routine questions related to study protocol; document all conversation in the
database.
• Audit investigator files.
• Tracked / Uploaded information into database.
EDUCATION
Jordan High School,Durham, NC
1975-1979
High School Diploma
Shaw University, Raleigh NC
1996-1997
Contact this candidate