Quality Assurance Project Manager

Crystal K. Little

*** ******** ******** ***. *** • Durham, NC 27703

Phone: 919-***-**** • Email: *******.******@*****.***

GOOD CLINICAL PRACTICE QUALITY ASSURANCE AUDITOR

Providing quality reviews of protocols, amendments, clinical study reports, data base audits, and additional study specific, and/or global process documents

Talented and accomplished quality assurance leader with over 7 years of experience and proven ability to successfully in achieving FDA compliance, and transparent audits. Highly successful in creating vision, identifying opportunities, and cutting costs while retaining productivity. Proactive self-starter with a demonstrated ability to manage projects, building relationships, communicates solution strategies, train and support staff. Team oriented and a creative problem-solver with the proven aptitude to analyze and translate compliance requirements and implement innovative solutions. Effective communication at managing relationships between strategic leadership, third-party vendors, and clients.

Therapeutic Areas: Oncology, Pharmacovigilance, Wound Healing, Vaccine, Pediatrics, and Cardiology.

Core Competencies:

Strategic Planning and Organizational Leadership New Systems Implementation

Internal/External Audit Management SOPs and GCP Regulations

Team Development and Leadership Project Management

Process and Productivity Improvement Regulatory Compliance Management

EDUCATION

Masters of Public Administration Expected Graduation: December 2012

N.C. Central University, Durham, NC

Bachelor of Science in Business Management May 2009

N.C. Central University, Durham, NC

PROFESSIONAL EXPERIENCE

NorthStar Research Institute, Inc., Cary, NC January 2009 – present

GCP Quality Assurance Auditor

Oversee the day-to-day management of the creation and review of standard operating procedures (SOPs), standard forms and templates, and study-specific procedural documents.

• GCP compliance and due diligence auditing including overall and study-specific compliance of the Clinical investigator site audits; Vendor and subcontractor qualification audits; and Internal operations compliance including process audits, process QC reviews, and departmental system audits.

• Independent database audits, Client systems audits, External vendors and Clinical investigator site, and Trial Master File audits.

• Audits of key deliverables and study components, including study process documents, trial master files, reports, tables, and listings.

• Development of Corrective and Preventive Actions (CAPA)

• Research existing literature and databases for supporting compliance information/use information to provide audit findings/recommendations for CAPAs

• Interact cross-functionally with internal and external groups regarding compliance issues

Durham County Public Health Department, Durham, NC August 2010 – May 2011

Graduate Intern- Part time

Working directly with the Local Health Director by assisting with the preparation and maintenance of departmental administrative policy and procedures; Interface with community representatives, government authorities, medical providers and vendors to develop federally funded programs for the county; Developing training manuals and conduct staff training.

Crystal K. Little page 2 of 2

North Carolina Central University, Durham, NC August 2009 – June 2010

Graduate Research Assistant – Part time

Worked directly with The Special Assistant to the Chancellor in developing all aspects of University policies preparation and implementation; coordinated and facilitated the University’s Educational Symposium; as well as, participated in the various University steering committees.

Talecris Biotherapeutics, Inc., Durham, NC October 2008 – January 2009

Sr. Quality Assurance Associate I - Consultant

Managed the development and implementation of software and computer system validation documentation reviews; as well as, all the organization’s Standard Operations Procedures (SOPs) and policies, in accordance to FDA and GCP/GLP/GMP guidelines. Reviewed, author & revised quality, operations and maintenance SOPs, in accordance to sponsor directives and regulatory guidelines. Planned, scheduled, conducted, and reported internal and site findings, resulting from audits; to key person of management.

King Pharmaceuticals, Inc., Cary, NC April 2008 – August 2008

Quality Assurance Coordinator - Consultant

Managed the corporate application TRAIN ComplianceWire Database for staff training. Managed Documentum (wrote, reviewed, and approved SOPs). Assisted departmental directors in coordinating SOPs and on-the-job training activities for over 100 employees. Ensured annual GCP/GMP/FDA training for all required employees, in according to FDA requirements

Wound Solutions Ltd., Cary, NC May 2007 – March 2008

CRA/Project Manager - Consultant

Managed all sites and clinical project team for 6 US sites and 5 international (UK) sites’ clinical research project. Assisted in the preparation of IDE submissions to FDA of “Fast Track” compounds of sponsor’s pipeline. Facilitated in the preparation of interim and final study reports to IRBs for specific compounds bordering safety concerns in according to regulatory agencies and FDA guidelines and policies. Performed routine and clinical study site identification, qualification, initiation, interim monitoring and close-out visits. Served as Lead Coordinator for sponsor’s 1st Investigational Meeting for wound care compound, assigned by Aerotek Scientific.

PAREXEL Inc., Durham, NC March 2006 – September 2006

Site-Study Start Up Analyst - Consultant

Responsible for the day-to-day operations and communication of site study-start up and site contract submissions and approvals to key persons of the Clinical Trial Team, Sponsors and Line Management. Responsible for generating, processing, and tracking changes for all clinical trials study sites (Phase I-IV) documentations.

BioMerieux, Inc, Durham, NC June 2002 – February 2005

Contract Administrator II

Liaison between Clinical and Research study teams, Legal, and clinical and research study sites to quickly develop contract agreements, negotiate terms, and execute agreements while maintaining strong customer partnerships. Trained and managed study sites and conduct/document study per protocol, in accordance to Food & Drug Administration (FDA) guidelines and sponsor SOPs.

PROFESSIONAL AFFILATIONS

The Graduate Association of Public Administration

Partnership for a Healthy Durham HIV/STD

American Society for Quality Association

NC Public Health Association

UIC Public Health Student Association

American College of Healthcare Executives

Contact this candidate