Project Manager Quality Assurance

GRACE JUNYING PENG

**** ******* **. *******, ** *7584

Phone: 281-***-****

E-mail: abnom3@r.postjobfree.com

SENIOR CLINICAL RESEARCH ASSOCIATE

Grace Peng, M.D.

EDUCATION

M.D., Medicine,

Southeast Medical University, China

Master of Science, Endocrinology,

Peking Union Medical College, Chinese Academy of Medical Science, China

Postdoctoral training, 2004

MD Anderson Cancer Center, Houston, TX

THERAPEUTIC EXPERIENCE

Infections/Parasitic Diseases: HIV, Diarrhea.

Oncology: Breast Cancer, Refractory or Advanced Malignancies, Pancreatic cancer, Lung cancer, Colon Cancer

Hematology: Sickle Cell Disease

Endocrine/Metabolic: Diabetes, Hypogonadism

Circulatory: Angina Pectoris

Respiratory: Asthma, ARDS, COPD, Allergies

Genitourinary: Gynecological tumor

Immunology: Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE) and Vaccine,

PROFESSIONAL EXPERIENCE

PPD, Houston, TX Regional Sr.CRA JUN 2006–MAR

2009

• Monitor phase I/II Refractory or Advanced Malignancies Clinical Trial

• Monitor phase II Systemic Lupus Erythematosus Clinical Trial

• Monitor phase II Rheumatoid Arthritis Clinical Trial

• Monitor phase III clinical trial: Effect of xxx on exacerbation rate in patients with COPD

• Monitor phase III clinical trial: Safety and Efficacy of xxx Nasal Spray in 6-11 Year Old Patients

• Monitor phase II Breast Cancer clinical trial.

• Monitor Phase II Ovarian Cancer clinical trial

• Monitor Phase II Cervical Cancer clinical trial

• Monitor Phase I/II Children Lymphoblastic Leukemia

Pharm-Olam International Inc. Houston TX Sr. CRA MAY 2005– MAY 2006

• Responsible for monitoring Phase I/II military diarrhea vaccine study

• Monitored regional/global studies within and across a variety of therapeutic areas including: oncology,

endocrinology, gynecological, hematology and preclinical trial. Accountable to ensure all relevant studies

follow applicable company or sponsor guidelines.

• Responsible for management of transplant treatment of Sickle cell disease clinical trial. Created project plan

and monitoring plan, set up project tracking system.

• Responsible for monitoring Phase II Breast Cancer PK study; Phase III GY oncology study; Phase III

Endocrinology study- Hypogonadism; pre-clinical Oncology study. Phase I diarrhea study.

• Responsible for performing feasibility for various trials

• Assisted with the design, development and implantation of protocols, CRFs and study supporting documents.

• Trained EDC user.

• Supported data management.

Tanox Inc. Houston TX Clinical Project Manager/CRA 2004–2005

• Responsible for of Phase I/II clinical trials in North America, m onitoring and co-monitoring with contract

CRA in the site visits. Specialty area: Oncology, HIV, ARDS and Asthma populations

• Management of CRO relationships, including initiation of Request for Proposals, proposal review

and contract negotiations. Responsible for planning, implementation, and management of clinical trials

performed by contract research organization (CRO).

• Management of clinical study conduct and operations including CRF design and implementation (traditional

paper and electronic data capture formats), drafted Informed consent and HIPAA authorizations, management

of contract CRAs/or outsourced CRO

MD Anderson Cancer Center, Houston, TX Postdoctoral 2001–2004

• Participated in drug development for Breast Cancer and Colon Cancer.

Quintiles Transnational Corp. Beijing China Clinical Project Manager

1997–2000

• Led the first two global clinical trials conducted at Quintiles China; a Phase III global cardiovascular-

Angina Pectoris clinical trial and a Phase III global RA clinical trial;

• Hired, trained and managed CRAs.

• Supported, planned, designed, implemented and executed clinical trials.

• Director of a multi-disciplinary team of CRAs involved in clinical operations and activities necessary to

support international Phase I- III clinical trials

• Coordinated shipping and handled clinical material samples and supplies.

American Pharmagene Company Beijing China Sr.CRA 1994–1997

• Participated in a Phase I and Phase II Lung Cancer and Pancreatic Cancer clinical trials. Monitored multiple

sites.

• Developed study protocols, documentation, case report forms, and project plans

Peking Union Medical College Hospital Beijing China Physician 1991–1994

• Participated in a Phase III endocrinology clinical trials-Diabetes study and ACTH diagnosis study as a sub-

investigator

PROFESSIONAL DEVELOPMENT

• PPD CRA Foundation Training

• PPD CTM training program

• Received Project Manager & Clinical Research Associate Training in Quintiles American for six

months Completed several Quintiles University courses on Clinical Operation, Project Management

and Drug Safety. Departmental observation in the following department: Project Management,

Clinical Operations, Drug Safety, and Quality Assurance.

• GCP & CRA mentoring Training in Quintiles Singapore.

PUBLICATIONS AND PRESENTATIONS

Publications:

Junying Peng, Funda Meric. Rapamycin mediated down- regulation of cyclin D1 expression through GSK-3B

signaling pathway. Cancer Research (Cancer Res 65(5): 1961-72.)

Woo-Chul Noh, Junying Peng, Funda Meric. Determinants of Rapamycin Sensitivity in Breast Cancer Cells.

Clin Cancer Research 10(3): 1013-23.2004

Junying Peng, Lu, Chaolin, Guo, Aili Rapid ACTH stimulation test and its Diagnostic value in hirsutism Journal

of Reproductive Medicine 1994 3(3) 135-139

Junying Peng, Lu, Chaolin, Guo, Aili The rapid ACTH stimulation test and the Initial Clinical application Beijing

Medical Journal 1994 16 (6) 323- 27

COMPUTER EXPERIENCE

Windows 95 – 98; Windows 2000; MS Word, Word Perfect, Excel, Access

EDC experience – Oracle and Inform

LANGUAGES

Proficient in Chinese

Contact this candidate