Quality Control High School
Resume:
Renata Roundtree
Philadelphia Pa 19144
*************@*****.***
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
Contact this candidate