Stefanie Barnett

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

Mount Juliet, TN 37122

615-***-****

aceacd@r.postjobfree.com

OBJECTIVE

I am seeking a clinical research position that will utilize my 10 years of

data/regulatory management experience and to continue my professional

growth within a well-established company.

EMPLOYMENT HISTORY

October, 2010 - January, 2014 Vanderbilt University Medical

Center

Clinical Research Associate II

. Responsible for monitoring and site management.

. Performed site evaluations and screening as assigned.

. Conducted pre-study and initiation visits with site personnel, ongoing

site monitoring visits and site closure visits as assigned per research

agreement.

. Developed patient recruitment strategies in conjunction with investigator

and site personnel.

. Monitored investigator compliance for the reporting of adverse events and

serious adverse events, and performed drug accountability and

reconciliation for all assigned sites.

. Knowledge of the Federal regulations and guidelines governing the

protection of human subjects (e.g., FDA, OHRP, GCP/ICH guidelines, and

HIPAA regulations).

. Reviewed the Institutional Review Board applications and communications

with the IRB.

. Maintained accurate source documentation and appropriate forms as per the

protocol including participant records, drug documentation, and

monitoring documentation for quality and accuracy.

. Therapeutic experience included: Oncology and Neurology

October, 2006 - October, 2010 Sarah Cannon Research

Institute

Regulatory Affairs Associate/Specialist

. Maintained the required regulatory documentation for over 40

individual sites within the research network.

. Ensured all the regulatory documentation is compliant with local Standard

Operating Procedures (SOP) for format and content.

. Modified and/or developed informed consent forms with updates.

. Worked closely with the department director and/or principal

investigators to ensure compliance.

. Monitored off-site network sites documentation according to protocol

guidelines.

. Created queries and requested missing data/regulatory files from

network sites.

. Processed initial study submissions, amendments, administrative changes,

investigator brochure updates, safety reporting, and study terminations

with the central IRB.

. Reported adverse events to the central IRB required by the protocol.

. Reviewed sponsor sites' files daily for up to date continuing

reviews, physician credentials, site and lab credentials.

. Organized and coordinated the IRB documentation for trials.

. Archived study specific regulatory documentation and correspondence.

. Reviewed study files and produced queries for network sites.

April, 2004 - October, 2006 Sarah Cannon Research Institute

Administrative Assistant

. Arranged travel and meeting preparations for two physicians.

. Typed manuscripts, articles, protocols, editorials, and reviews.

April, 2000-November, 2003 Deutsche Bank

Benefit Payments Administrator

. Accounts Receivable/Accounts Payable

. Processed pension payments for Fortune 500 clients

EDUCATION

May, 1991

Degree: Associate of Science in Business and Commerce

Volunteer State Community College

CERTIFICATION

Certified Clinical Research Professional (CCRP)

SKILLS

Salesforce, InForm, Medidata Rave, Microsoft Word/Excel, Microsoft Outlook,

Powerpoint, Access, Internet, Data and Regulatory Management,

Auditing/Monitoring, Adverse Event Reporting, Accounts Payable/ Receivable,

Data Entry, Consenting Patients and Laboratory Shipments.

COMMITTEES/AWARDS

Vanderbilt ELEVATE Committee - Events/Activities Committee

Sarah Cannon Research Institute Employee Advisory Committee - Chair for the

Volunteer Committee

2008 Frist Humanitarian Award

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