Renata Roundtree

*** * ******* ****** *-***

Philadelphia Pa 19144

267-***-****

acpdvz@r.postjobfree.com

PROFILE:

* Clinical Trial Master File experience, specializing in Regulatory documents processing, eTMF, ANGEL, PTMF and GEL submission systems.

* Knowledgeable of FDA regulations and SOPs. Worked closely with Therapeutic and Oncology studies.

* ICF approval and submission processing

EXPERIENCE:

AstraZeneca, Wilmington DE May 2014- January 2015

Clinical Study Associate (Contract)

* Liaison between study team and CRA’s, Processing 1572’s and CV’s into eTMF, in charge of therapeutic studies for submission to FDA in a timely matter. Meeting with study team to ensure quality of regulatory document processing.

* Submitting regulatory documents to the ANGEL and GEL system to be submitted to FDA.

ICON Clinical Research, North Wales PA September 2011- May 2014

Documentation Specialist

* Filing Clinical Documentation into Trail Master File (TMF) Process study documents in accordance with ICONs SOPs, SAE processing, SUSAR processing, Financial Disclosure processing.

* Ensuring the quality of Regulatory documents through pTMF’s Quality Control system.

* Work with various starts up and close out study documentation.

* 1572 and CV processing.

PhlexGlobal, Malvern PA May 2011-September 2011

Document Administrator (Contract)

* Tracking receipt and process of all clients Trial Master File and ongoing study documentation.

* Tracking document input using excel spreadsheets.

* Scanning study documents, Ad hoc general document administration. Processing of GMP compliance documentation, inputting study documentation in ACCEL software.

Huntington Valley PA June 2010-Oct 2010

Document Specialist, Alpha Systems (Contract)

* Prepping medical records to be scanned, Quality control of all documents scanned to ensure accuracy, organizing and filing patient information, prepping hospital charge to be scanned.

* Tracking documents with Microsoft Excel.

EDUCATION:

Eastern University- Associates Degree, 2014

Strawberry Mansion High School Diploma, 2003