Quality Assurance Manager

Hong T. Pham, MBA, BS

Current Address: *** ***** ******, *** *******, TX 78210

Future Address: 6300 Girard, Unit #4, Cincinnati, OH 45213

Phone: 504-***-**** • E-mail: ******@*****.***

OBJECTIVE Quality Assurance Auditor position with an independent consulting firm providing services to the

pharmaceutical and biotechnology industry

QUALIFICATIONS Performed extensive quality assurance of source data for multiple protocols and revision of

Investigator site’s Standard Operating Procedures

Ensured the completion of GCP training for study staff members

Supervisory and managerial experience in oversight of study protocols and conduct of clinical

research studies

Experienced in start-up of all clinical research studies at Investigator site

Excellent analytical and interpretive skills

Excellent communication and collaboration

Diligent, autonomous, and self-motivated

Meticulous and professional

Strong work ethics

EDUCATION Master of Business Administration 2003-2005

University of New Orleans, New Orleans, LA

Bachelor of Science in Biology 1999-2003

University of New Orleans, New Orleans, LA

PROFESSIONAL Regulatory Manager / Project Support Manager 2007-Present

EMPLOYMENT Sun Research Institute, San Antonio, TX

• Provide support, guidance and assistance to the Institution’s President, study coordinators

and clinical investigators

• Provide in-house quality assurance with review of source documents, case report forms and

regulatory documents on all studies conducted at Institution

• Ensure FDA regulations pertaining to drug research are observed and that the

pharmaceutical company objectives are understood and met

• Ensure compliance with all applicable regulations, Good Clinical Practices and regulatory

authorities, and protocol

• Responsible for all duties as a study coordinator

• Responsible for training of study coordinators and assistance in the supervision of the

conduct of clinical trials

• Provide continuing education for study coordinators and clinical investigators regarding

clinical research and maintain appropriate records of training

• Provide ongoing review of all study documents and verification of Case Report Form data

• Design source documents for study protocols

• Submit start-up regulatory documents to pharmaceutical companies and Institutional Review

Boards

o Design and submit site-specific study advertisements

o Complete and submit annual and interim study status reports to the IRB

o Maintain regulatory files on all studies

• Create and maintain curriculum vitas on all physicians and study personnel

• Maintain financial accounts for all studies conducted at Institution

o Negotiate and finalize study contract and budget

o Maintain accounts receivable records and provide semi-monthly report to

President/Clinical Director

o Invoice study advertising and pass-through costs

o Reconcile final payments at study closure

• Act as communication liaison between CRO/Sponsor and research staff

• Maintain and update Institution’s Standard Operating Procedures to ensure compliance is

met in all areas of operation

Benefit Analyst 2006-2007

Strategic Employee Benefits of Louisiana, Metairie, LA

• Acted as intermediary between business clients and healthcare insurance carriers to

provide insurance coverage to employers. Managed 15-20 employer accounts.

• Provided quarterly medical insurance reports and spreadsheet analyses detailing

enrollment, demographics, savings, and medical/prescription expenditure and utilization.

• Handled the processing of annual health insurance renewals

• Marketed medical, dental, vision, life, and disability insurance plans to preferred insurance

carriers.

• Communicated competitive market information to benefit Manager/consultant to obtain the

best health savings for clients.

Spine Patient Research Coordinator 2005

LSU Health Sciences Center at Children’s Hospital, New Orleans, LA

• Met with patients and parents to enroll new spine patients into ongoing research study.

• Followed up on existing pediatric spine patients post-operatively for consecutive periods.

• Developed an efficient and reliable method of data collection within the clinic for the

management of consistent patient follow-up data.

• Improved patient enrollment in research study from 10 patients to 40 patients within six

months.

• Prepared documentation to obtain approval from institutional Review Board for new,

upcoming studies and projects.

• Trained student worker in basic research tasks and general office duties.

Phlebotomist 2003-2004

The Blood Center of Southeast Louisiana, New Orleans, LA

• Ensured smooth and efficient blood donor flow.

• Determined donor acceptability.

• Performed sterile venipuncture for the collection of a unit of whole blood.

• Ensured quality products throughout the phlebotomy process.

Student Researcher 2002

LSU Health Sciences Center, Department of Epidemiology, New Orleans, LA

• Selective summer program funded by the National Cancer Institute for a short research

experience in cancer under the supervision of a mentor.

• Conducted secondary statistical analysis to determine the effect of alcohol consumption

on the risk for colon cancer.

• Obtained working knowledge of SPSS.

• Developed oral and written skills in research presentation of results.

CLINICAL An experience list of past clinical research studies is available upon request.

RESEARCH

STUDIES

LANGUAGES

Fluent in Vietnamese

Introductory Spanish

SKILLS Advanced in Microsoft Office (Word, Excel, PowerPoint)

Experienced in MAC OS

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