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Customer Service Medical Assistant

Dublin, CA, 94568
August 13, 2012

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**** ***** ******

Dublin, CA 94568

Cell: 925-***-****

Email address:

OBJECTIVE: Eleven years of progressively increasing experience in Clinical Operations in the Pharmaceutical industry with a focus on Oncology/Hematology

EXPERIENCE: TS BioPharma, Walnut Creek, CA 03/12 present

Clinical Research Associate Contract

Responsible for ensuring the verification of source documents against case reports forms. Review regulatory documents, investigational product accountability, and prepare site visit report. Ensure the sites are following the study schedule of the protocol and in compliance with GCP/ICH guidelines. Ensure all the patients enrolled are consented properly.

Valley Medical Oncology Consultants, Pleasanton, CA 01/12 present

Clinical Trial Coordinator/Medical Assistant Part time

Responsible for ensuring all aspect of clinical studies for Valley Medical Oncology Consultants (VMOC) including start up of phase III, IV, and observational cancer trials. Initiate and finalize Institutional Review Board (IRB) approval, site contract, prepare site pre-qualification and initiation visit from Sponsor. Prepare VMOC for Institutional BioSafety Committee (IBC) inspection. Ensure compliance with IRB and sponsor study protocol. Complete IRB and Sponsor Regulatory documents as needed, including Adverse Events, Serious Adverse Events, and 1572 form. Screen potential subjects for protocol eligibility. Enter patient data into Oracle electronic data capture. Medical Assistant duties includes taking patients vital signs, blood draw, injections, documenting on patients chart and documenting chief complaints, as well as rooming patients.

Veterans Hospital---Internship, Livermore, CA 04/11--6/11

Medical Assistant 130 hours

Check patients in for their appointments. Call patients for rescheduling and making appointments. Cancel patient appointments in the VA system. Take vital signs and room patients in the hospital. Observe Nitrogen 200 sprayed onto skin cancer, blood transfusion, EKGs, and X-ray films.

Family Business, Walnut Creek, CA 11/08 04/11

Supervise day to day operations, customer service, and money management, ordered and processed inventories, delegate duties to subordinate.

SuperGen, Inc., Dublin, CA 08/97--11/08

Senior Clinical Research Associate

Responsible for ensuring that all clinical operations study start-up related activities remain on track in order to meet “First Patient In” enrollment target timeline for Solid Tumor Phase 1 trials. Tracking and managing the patient enrollment-critical timely review of safety lab data; contact CRO for safety follow up and provide management enrollment status every two weeks for the study. Manage and mentor non-exempt staff. Manage start-up activities.

Duties: request/review proposals from CROs/study vendors; generate consent form templates and assist sites with the review / approval of consent forms for IRB / Ethics submission, protocol / CRF design review, and preparation of study binders (Investigator, Regulatory and Pharmacy Manuals). In addition, provide team updates regarding start-up activity status (i.e. site regulatory submission updates, study binders / materials and vendor related activities). Assist in the interview / selection process of site monitors and study vendors. Oversee the eCRF (RAVE) and CRF for phase 1 studies. Collaborate with various SuperGen departments (i.e. QA, Regulatory, Safety, Pre-clinical, Data Management, Accounting and Legal) for study specific needs and ensure consistent information is communicated across functions. Conduct CRA training during kick-off meeting, pre-study visits and site initiation visits. Oversee retired trial management system: (TrialWorks) and introduce new trial management system: (TranSenda). Supervise the archiving of all documents/files for Clinical Operations/Clinical Research, Safety and Data Management to an offsite location. Manage the storage and distribution of clinical investigational products along with forecasting future requirements for all active studies. Create, maintain, and update Material Safety Data Sheets (MSDS) for all investigational products.

Other positions held while employed at SuperGen:

Clinical Research Associate/Lead Clinical Research Associate

Data Coordinator

Administrative Assistant/Data Coordinator

Administrative Assistant 1

TECHNICAL SKILLS: CPR/First Aid Certified, Medical Filing, Medical Terminology, Anatomy, Phlebotomy, Injections, Vital Signs, Patient Preparation, EKGs Set-up for Minor Surgery, Assist with Exams, Basic Lab Tests, Wound Care, Specimen Collection, Sterile Tray Setup, Customer Service and Patient Logistics, Medical Law and Ethics, HIPAA Awareness, Data Entry, Office Logistics. Advanced skills in Microsoft Word, Excel, PowerPoint and Access. Typing skills: 62 WPM.

PERSONAL SKILLS: Multilingual- Malay, Punjabi, Hindi. Excellent customer service skills. Proven record of reliability and dependability in positions. Detailed oriented. Flexible in organizing, project priorities and exercising good judgment. Support company initiatives relating to Ethics, Safety, and Diversity.

EDUCATION: California Certified Medical Assistant, Administrative, and Clinical

(Cert no.11127-12)

Mission Valley Regional Occupational Program, Fremont, CA

Clinical Medical Assisting (06/2011)

Administrative Medical Assisting Certifications (06/2011)

Martinez Adult Business School, Martinez, CA

Medical Secretary

Computer Operator Certifications

Professional Training

Good Clinical Practice Orientation Training (PPD)

Clinical Monitor Training – GCP & SAE (SuperGen Inc.)

SAS Fundamental Course (SAS Institute)

Introductory SAS Techniques: Data Management & Programming (Virtu Stat.Ltd)

Discovering the Secrets of Microsoft Access (CompuMaster)

GCP Documentation/File (SuperGen Inc.)

GCP/GLP (Parexel Intl.)

Management Training (SuperGen Inc.)

CRA Training (SuperGen Inc.)

Project Management for Clinical Trials Course (PTI)

Advanced Clinical Research Associates Training Course (DIA)

GCP and GLP Training (Parexel International Corp.)

ACRP Annual Conferences

DIA Annual Conferences

Intermediate CRA (ACRP)

Project Manager (ACRP)

Business Emergency Safety Training (SuperGen Inc.)

IATA/49CFR Dangerous Goods Training (Indianapolis, MN)

Investigational Clinical Supplies: Conceptualization, Planning, Manufacturing, Packaging,

Labeling, Analytical Testing and Global Distribution Issues (Toronto, Canada)

Investigational Clinical Supplies: Good Manufacturing Practices (cGMPs) in the Global

Clinical Development Environment (Toronto, Canada)

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