Project Clinical

Ijeoma C. Nwankwo

* ******** *** *********, ** **042

P: 908-***-**** E: ******.*******@*****.***

PROFESSIONAL DEVELOPMENT

Technology Skills: Microsoft Word, Excel, PowerPoint, Adobe, InnTrax,

Clinical Informatics, Interactive Voice Response System (IVRS), Sharepoint

Training: ICH-GCP guidelines, Therapeutic modalities and clinical trials in

cardiovascular and infectious diseases

Awards: Recognition award for assisting clinical team in launching the

startup of the new site for an H1N1 trial

EDUCATION

University of Medicine and Dentistry-School of Biomedical Science

Newark, NJ

Masters in Biomedical Sciences, 2008

Rutgers, The State University of New Jersey

New Brunswick, NJ

Bachelors of Science in Exercise Science and Sports Studies, 2006

RELEVANT WORK EXPERIENCE

Senior Clinical Trial Assistant

October 2008-Present

Quintiles Transnational Corporation, Parsippany, NJ

. Supported clinical team leads (CTLs) and clinical research associates

(CRAs) with accurately updating and maintaining clinical systems that

track site compliance and performance within project timelines.

. Collaborated with 4 CTLs on the preparation, handling, distribution,

filing, and archiving of clinical documentation and reports according

to the Scope of Work (SOW) and Standard Operating Procedures (SOPs) in

Infectious Diseases and Women's Health trials

. Coordinated in the development of a new file plan for the organization

and accuracy of site documents during study close out

. Assist with periodic review of Trial Master File (TMF) for accuracy and

completeness

. Collaborated with CTLs on the preparation, handling and distribution of

clinical trial supplies and maintenance of tracking information.

. Managed 100 sites on a national study through the startup, maintenance,

and close out phase of the study

. Collected and retrieved regulatory documents while onsite on post

close out visits (COVs)

. Assisted with the tracking and management of case report forms (CRFs),

queries and clinical data flow.

. Tracking and reconciliation of data clarification forms (DCFs) while

onsite

. Acted as a central contact for the clinical team for designated project

communications, correspondence and associated documentation.

. Acted as a liaison between the sites and the central and local

Institutional Review Board (IRB) to ensure timely approval for protocol

amendments and other regulatory documents

. Assisted in training and orienting new staff; acted as a mentor for

novice CTAs

. Participated in the planning of an Investigator Meeting for the startup

of the H1N1 trial in Orlando, FL

Surveillance and Safety Coordinator

December 2007- October 2008

Pfizer Inc., New York, NY

. Received all potential reports of adverse events through the electronic

mailbox and Case Receipt application to ensure timely processing

. Validated all adverse event reports and forwarded to appropriate

therapeutic area team for triage

. Communicated with Pfizer affiliates, licensing partners and various

submitter agents regarding report submissions

. Interacted with the therapeutic area teams, compliance and other

functional groups to ensure adherence to processes and procedures

. Actively participated in Case Receipt and therapeutic team meetings

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