Sean Du, M.Sc

***-**** ***** ********, ******, Canada H2X 2B1

514-***-****(home) abqir4@r.postjobfree.com

Canadian citizen

Objectives

Clinical Research

Highlights of QualificationsCompleted graduate study in both of clinical research and basic medical research at McGill University, Certificate of Clinical Research, Good knowledge of ICH GCP guidelines, FDA, Health Canada regulations.Sound knowledge of clinical trial, evidence-based medicine, system review, biostatisticsSolid working experience gained from a variety of backgrounds, including clinical research, clinical medicine, and basic medical researchConfidence and experience in communication with physicians, health-care practitioners and patientsComprehensive knowledge gained in various education fields: clinical medicine, clinical research, biochemistry and experimental medicine Proficient in various computer applications Overseas living experiences and cross-culture sensitivityBilingual: English and Mandarin (Fluent in written and verbal)

ICH-GCP TrainingPreparation/approval/distribution of Informed Consent Form (ICF), Extended Synopsis, Clinical Trial Protocol, Clinical Trial Protocol Amendment; Preparing/maintaining/archiving product file and study files; Preparation of required documents for IRB/IEC submissionPreparing/ordering/shipping clinical supplies; Investigational Product tracking/reconciliation/destruction; Code Breaking Procedures; Managing Interactive Voice Response System (IVRS) for clinical trial (randomization process, randomization code release)Pharmacovigilance/Clinical safety data management (SAE, SUSAR, CIOMS); Implementation of Data Monitoring Committee (DMC) in clinical trial; Management/workflow of Case Report Forms (CRF) and Discrepancy Resolution Forms (DRFs); CRF preparation to distribution; Focused and random source data verification (SDV); Quality/Integrity of electronic records at clinical investigator sites; Scientific misconduct / serious GCP non-compliance; Health Canada InspectionsSelecting potential Investigators/study sites; Performing study site initiation; Conducting/reporting routine monitoring visit; Conducting co-monitoring visit; Closing clinical trial at study site; Site transfer process; Preparing/approving/dispatching monitoring plan

experiences in Clinical trials

Department of internal medicine, surgery, NanJing, China 1999-2002

Sub-investigatorEvaluate the Aminobisphosphonate (APD) in control of pain in patients with bone cancer. Phase 3 study recombinant human p53 adenovirus injection in patients with sarcoma. Phase 1 and 2 studies.Examine the efficacy of JingGu capsule (Chinese medicine) in treating adult with osteoporosis. Phase 2 study

McGill University Health Center Canada 2008-2011

Clinical research coordinator/assistant Trial of Glutamine and Antioxidant Supplementation in Critically Ill Patients (REDOXS)PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)Candida in the Respiratory Tract Secretions of Critically Ill Patients and the Efficacy of Antifungal Treatment (CANTREAT)

Third party independent clinical trials company China 2011-2012

Supervisor

Leader of CRA team

Working History and responsibilities

Montreal General Hospital, Royal Victoria Hospital, MUHC, 2008-2011

Montreal, Canada

Clinical research assistant (Cardiovascular Division)

System review, study design, research papers writing

Clinical research coordinator (Critical Care Division)Review patients’ charts, screen and recruit eligible patients, obtain informed consent, monitor patients' study progress to fulfill protocol and sponsor requirementsData collecting, data maintaining through Electronic Data Capture (EDC) systemCommunicate with physicians, patients and family members, as well as other staffs involved in studiesInitiate, and maintains required clinical and regulatory files, studies close-out Coordinate protocol implementation for clinical trials, prepare and submit the regulatory documents, Participate in conferences, meetings as assigned.

Hormones and Cancer Research Unit, McGill University Health Center, Montreal, Canada

2006 - 2008

Graduate Research Assistant

Pre-clinical studies, applied a variety of bio-technological approaches in my research, including cell culture, PCR and real time PCR, Molecular cloning (sticky end and blunt end cloning), DNA transfection and siRNA, Site-directed mutagenesis, Luciferase assay, Protein analysis by SDS PAGE, western blot

Department of pharmacology, Sherbrooke University, 2003-2005

Sherbrooke, Quebec, Canada

Summer Research Assistant

Main responsibility: prepare protein sample, analysis by MS

Department of internal medicine, and surgery, NanJing, China

Medical Doctor (5 year’s Resident in internal medicine and general surgery, and 3 year’s Attending Doctor) Worked as sub-investigator to conduct and monitor clinical trials for various pharmaceutical companies under direction of principal investigator

1994-2002 Internship rotation in different sectors of Department of Internal Medicine for 3 years, short stay in pediatric, gynecology & obstetrical and radiological DepartmentInternship rotation in different sectors of Department of Surgery for 2 years, main stay in General Surgical DepartmentDiagnosed and treated orthopedic patients, Restore and fix bone fractures, Conducted hip replacement and intervertebral disk herniation surgery supervised by senior doctor

Education

M. Sc, Clinical research, Experimental Medicine, McGill University, Montreal, QC, Canada

2006 - 2009

B. Sc, Biochemistry (major), English Language (minor),

Bishop's University, Sherbrooke, QC, Canada

2003 - 2006

Bachelor of Clinical Medicine XuZhou Medical College, JiangSu, China

1989 - 1994

Certificate of Good Clinical Practice Kriger Research Center Inc

2009

Computer Skills

Microsoft Word, Excel, PowerPoint, Adobe Photoshop, Reference Manage

Publications and presentations

Angiotensin II receptor blockers in patients with heart failure and Comparison of dose-response of angiotensin II receptor blockers in patients with heart failure population-based study XiaoJian Du, Clinical Research Program Project

XiaoJian Du, Cindy Baldwin, Erika Hooker, Pauline Glorion and Serge Lemay Basal and Src kinase-mediated activation of the EphA2 promoter requires a cAMP-responsive element but is CREB-independent. (Published in Journal of Cellular Biochemistry)

Oral presentation Role and regulation of Eph/ephrin signaling in renal ischemia-reperfusion injury Hormones and Cancer Research Unit, McGill University Health Center, Feb 4, 2008

Poster presentation Src kinase-mediated activation of the EphA2 promoter is dependent on CREB but independent on P53, by XiaoJian Du, Cindy Baldwin and Serge Lemay, Kidney Annual Research Day, University of Ottawa, Aug. 2007

Poster presentation Stimulation of MDCK Renal Tubular Cells with an EphA2 Ligand Disrupts Cell-Cell Junctions Increases Transepithelial Permeability and Causes Dephosphorylation Of VASP, Cindy Baldwin, XiaoJian Du and Serge Lemay, Kidney Annual Research Day, University of Ottawa, Aug 2007

COURSES ATTENDED

Clinical Trial Inspection Program

Ms. Solange Rivard & Ms. Louise Jodoin, Drugs Specialists, Health Canada

Clinical trial design and implementation: a practical example

Dr. Catalin Mihalcioiu – MUHC Royal Victoria Hospital

Clinical Trials in Radio-Oncology: Design and practical aspects

Dr. George Shenouda – MUHC Royal Victoria Hospital

Molecular modeling: a tool to investigate tyrosine kinase inhibitors

Dr. Christopher Williams – Chemical Computing Group Inc.

The Drug Approval Process for Investigator Initiated Studies: A Practical Example

Dr. Brian Gilfix – MUHC Royal Victoria Hospital

Phase I Clinical Trials in Oncology: Principles, Design and Outcomes

Dr. Sarit Assouline – MUHC Jewish General Hospital

Ethics of Experimental Therapeutics

Dr. Denis Cournoyer (MGH) Director, MUHC Research Ethics Office

Introduction: Basic Concepts in Therapeutic Drug Monitoring

Dr. Brian Gilfix (MUHC - RVH)

Provincial Program for Antiretroviral Therapeutic Drug Monitoring

Dr. Niamh Higgins (MUHC – Mtl Chest)

Technical Advances in Therapeutic Drug Monitoring in HIV Research

Dr. Bernard Gibbs (McGill U – Sheldon Biotechnology)

Pharmacogenetics And Modern Genotyping Technology

Dr. Brian Gilfix (MUHC - RVH)

Beyond Antiretroviral Therapy: New Frontiers Based on HIV Pathogenesis

Dr. Jean-Pierre Routy (MUHC – RVH)

Modern approach to cancer drug development

Dr. Bertrand J. Jean-Claude – MUHC RVH

Ovarian cancer: the need for a paradigm shift and our endeavors with a kinase inhibitor

Dr. Walter Gotlieb – MUHC JGH

Contact this candidate