Project Manager Data
Resume:
E ste r Sie
Seal Beach, CA 90740
*********@*****.***
EXPERIENCE
University of Southern California, General Surgery May 2007 Nov 2012
Los Angeles, CA
Clinical Trial Specialist
• Participated in over 60 Clinical Trials with more than 20 Sponsors
• Responsible for investigation, data collection, and reporting Serious Adverse Events (SAE) to
Sponsor and Institutional Review Board (IRB) of University of California (USC)
• Responsible to create Standard Operating Procedure (SOP) and in house protocol training and
following up of Adverse Events (AE)
• Optimize studies for phase I, II, III, and IV surgery and medical device with the Principal
investigator’s to optimize Good Clinical Practice (GCP), to meet demands of the Food and Drug
Administration (FDA)
• Manager of clinical trials for physician initiated studies, and industrial studies for Los Angeles
County General Hospital, Norris Cancer Center and Keck Hospital
• Responsible for communication between sponsors of medical devices, pharmaceutical companies,
and IRB USC
• Responsible of reporting the Investigational New Drug (IND) and Safety Reports between Sponsors
and USC IRB
• Responsible for data collection from USC Medical Records, and capturing electronic data provided
to Sponsor in a timely manner
• Analysis of Correction Action Request (CAR), and Data Queries
• Eliminate discrepancy reports between subjects and case report forms
• Communication and review analysis with Sponsor and Monitor
• Responsible for data clarification and recordation within case report forms, source documents,
original medical records, laboratory, and diagnostic reports
• Responsible for daily, weekly, quarterly, semi annual, and annual evaluation for individual and team
metrics and improve efforts in clinical trials
• Actively present to research team and PI on a weekly base
• Managing budgets with USC CRO, PI and MCA
• Regulatory role: IRB submission, revising the Informed Consent and HIPAA
• Responsible for Sponsor and Clinical Research Associates while running the study initiation the
visits, monitoring visits and closing out each visit
• National travel representing USC with Sponsors and Investigators
• Collaboration with surgeons to create protocol, research data base, research publication, and case
report forms
University of Southern California, Colorectal Surgery May 2006 May 2007
Los Angeles, CA,
Data manager
rese
• Team member responsible for enrolling patients during phase I, II, III,and IV oncology, surgical
device, and pharmaceutical studies
• Managed budgets with USC CRO
• Monthly performance reviewed with Principal Investigators
• Administrator for optimizing protocol, data collection and matching sponsor requirements with
clinical trials
• Supported project manager for site visits, initiation, monitoring, and close out
• Accountable for investigations, data collection and reporting the Serious Adverse Events(SAE) to
Sponsor, and USC IRB
Bay View Research Group September 2005 April 2006
Studio City, CA
Study Coordinator
Role: Coordinate Phase IV and post marketing studies for Osteoarthritis, Gastritis and Alzheimer ’s disease
• Collected data with EDC and specimen for study
• Provided for study initiation visit, monitoring and close out visit
• Conducted patient follow up, drug accountability, reported to Study Monitor
• Pre screened, screened and assisted with consent process
• Data management from: patients, charts, and transferred the data onto Electronic Data Captured
into forms and communicated results with Sponsor
• Assisted in Correction Action Request forms responses to Data Queries
Department of Neuroscience, UCLA December 2003 January 2005
Los Angeles, CA
Volunteer Study Coordinator
Phase I study for electrode implant to Epilepsy Patient’s Brain
• Recorded and Analyzed electronic impulses from Epileptic Human Brain
• Investigated electronic impulses from mice brains in the animal labs
• Collected samples of epilepsy patient CT scan
• Screened and managed over 100 patients on a monthly basis
Private Practice of Obstetric and Gynecologist January 2000 – December 2002
Jakarta, Indonesia
Assistant to Professor, Rustam E. Harahap, M.D, PhD
• Performed colposcopy examination and cervical biopsy for patients who have abnormal pap smear
and where doctor indicated additional testing required
• Conducted client pap smear examinations
• Educated cervical cancer patients regarding their treatment and diseases
• Trained staff, incoming nurses, and medical assistants
• Screened patients who had potential of cervical cancer and enrolled them to cancer therapy or
cancer clinical trials
PARTICIPATED IN STUDIES
American Society of Colon and Rectal Surgeons (ASCRS)
J. J. Choi, P. Lee, E. Sie, A. J. Senagore. Management of Anorectal Disease in Leukopenic patients at a
County Institution.
Vancouver, Canada., May 2011.
American Society of Colon and Rectal Surgeons (ASCRS)
J. J. Choi, P. Lee, E. Sie, A. J. Senagore.
Predictors of Surgical Site Infections are Dependent on Patient Population.
Los Angeles, CA., May 2011.
Association of Colorectal Surgeons (ACS)
J. J. Choi, P. Lee, E. Sie, A. J. Senagore.
A Retrospective Review after Implementing a Physician Driven Enhanced Recovery Protocol with Limited
Resources at a County Institution.
Los Angeles, CA., 2011.
Digestive Disease Week
A.M. Kaiser, E Sie, R.W. Beart, P. Vukasin, G. Ault., Negative Prognostic Parameters Associated with Fatal
Outcome of Clostridium difficile colitis.
Washington DC., May 2007.
TECHNOLOGY
Proficient in Adobe, Windows Vista, Windows, Microsoft Office, Excel, PowerPoint, Publisher, Word,
Microsoft Project Manager
EDUCATION
AtmaJaya Catholic University Jakarta, Indonesia
Doctor of Medicine Graduated: May 2002
• Graduated as General Practioner of Medicine
• Affiliate member of Association of Clinical Research Professionals (ACRP)
• Participating within the Society of Clinical Research Associates (SoCRA)
• Currently pursuing Certified Clinical Research Associate (CCRA) Certification
• Studying for Certified Clinical Research Professional (CCRP) Certification
Ongoing: Continuing Education Training and Certification @ USC
• Contract and Grant, Clinical Translational
• Project Management Fundamental, Microsoft Project Management
• Training Leading and Managing Research Team by SC Clinical Translational Science Institute
(CTSI)
LANGUAGES
Indonesian
English
REFERENCES AVAILABLE UPON REQUEST
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