Phyllis Hedgepeth

**** ******* ******

Durham, NC 27707

919-***-****

ace3mh@r.postjobfree.com

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

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