Clinical Assistant

LEE ANN JAMES

Tel: 916-***-****

E-mail: *****.******@*****.***

http://www.linkedin.com/in/leeannjames1

Clinical Trial Associate - Medical Device and Pharmaceutical Studies

A successful Clinical Trial Associate with over 10 years’ experience in supporting both medical device and pharmaceutical Phase I, II, III, and post-marketing clinical trials. Knowledgeable in FDA, IRB, ICH, GCP and HIPPA requirements. Extensive experience providing a full range of regulatory documentation management services for clinical trials. A versatile professional that works effectively either independently or as a team player (internal and external partners) to consistently achieve project objectives.

KEY AREAS OF EXPERIENCE

Team Player ~ Customer Service ~ Motivator ~ Multi-Tasking ~ Time Management ~ Goal Oriented ~ Self-Starter ~ Clinical Trials ~ New Drug Applications ~ Knowledge in FDA Requirements ~ Regulatory ~ Advisory Boards ~ Institutional Review Board ~ Clinical Trial Management Systems ~ Phase Forward Database ~ Study Start Up ~ Study Close Out ~ International Harmonization Code ~ Good Clinical Practice Guidelines

PROFESSIONAL EXPERIENCE

Ventus Medical, Inc. – Belmont, CA

A privately funded medical device company that developed and commercialized Provent® Sleep Apnea Therapy

Clinical Trial Associate (Consultant) July 2009 – March 2011

Managed clinical trial documentation for a 250 patient, 19 center, post-marketing study as well as multiple investigator initiated and market research projects.

• Managed an electronic master document tracker to ensure timely receipt and organization of required study documents exchanged between the study sites and Ventus (financial disclosure form, protocol signature page, IRB approvals, clinical trial agreements, site/sponsor correspondence)

• Extracted reports from the electronic data capture (EDC) system by Phase Forward to create detailed invoices and generate monthly clinical trial payments to19 study sites

• Created, organized and maintained both hard copy and electronic document archives

• Ensured that required clinical trial documentation was audit-ready at study close-out

• Facilitated the inventory, return, reconciliation and archival of study equipment/supplies

• Handled payments to Institutional Review Boards (IRB), third party data management providers (Phase Forward and ARA), core labs, and a variety of study supply vendors.

• Provided accurate monthly expense accruals to the finance department.

• Developed case report forms and supported IRB submissions

• Provided administrative support to the Clinical Affairs Department, including the department Director, Manager, a team of 3 field-based Clinical Research Associates and a clinical affairs consultant

• Provided (as needed) support to the R&D team with testing and device assembly

Accomplishments:

Led the reorganization of the complete Trial Master Files to meet FDA document retention requirements

Audited and reconciled study site payments

Theravance, Inc. – South San Francisco, CA

A small venture financed bio-pharmaceutical company focused on the discovery of therapies in respiratory disease, bacterial infections and gastrointestinal motility dysfunction

Clinical Trial Associate (Consultant) October 2008 – July 2009

Audited clinical trial documentation from 140 countries for a new bacterial infection therapy, Telavancin®, and ensure its compliance with FDA requirements

• Managed, organized and compiled data for an FDA New Drug Application (NDA)

• Conducted follow-up on all documentation with Principal Investigators

• Validated translation certificates for international clinical trial documentation to be included into the Trial Master File (TMF)

Accomplishment:

Assisted in the FDA audit of Televancin global study (140 countries)

Genentech – South San Francisco, CA

A multinational biopharmaceutical company developing and commercializing innovative therapies in various therapeutic categories.

Clinical Trial Associate (Consultant) May 2005 – May 2007

Organized and maintained the documentation, clinical supplies and processes for Phase I through Phase III clinical studies.

• Prepared and distributed the Regulatory Package (i.e. Form 1572, Financial Disclosure Form and Protocol) to the Clinical trial sites

• Coordinated the logistics of the investigational product to the clinical sites

• Managed payments to Principal Investigators

• Verified completeness of data in clinical trial case report forms

• Processed data into designated Clinical Trial Management Systems (CTMS)

Accomplishment:

Audited and reconciled clinical study site payments to recover of 30% of investigator fees

Quintiles Pacific - Mountain View, CA

A multinational Clinical Research Organization (CRO) serving the pharmaceutical and biotechnology industry.

Clinical Trial Associate November 2003 – May 2005

Supported several clients in the preparation and execution of clinical trials in various phases including study start up and close out activities.

• Conducted comprehensive management of clients clinical documentation and reports

• Managed client projects to achieve milestones and study goals

• Provided administrative support to the CRA Team

Accomplishment:

Completed all assigned projects successfully, on schedule and within budget

CV Therapeutics, Inc. - Palo Alto, CA

A pharmaceutical start-up company focused on the discovery of drug molecules for the treatment of cardiovascular diseases. Acquired by Gilead in 2009.

Executive Administrative Assistant to VP, Clinical Operations July 2001 – November 2003

Performed administrative duties for the VP of Clinical Operations and the Executive Management Team. Prepared strategic clinical and legal documents.

Accomplishments:

Supported the submission of the company’s first NDA for Ranexa®

Organized and managed a milestone 3-day Advisory Board meeting for Ranexa

Guidant Corporation - Santa Clara, CA

An innovative medical device company specializing in cardiovascular products including pacemakers and stents. Acquired by Johnson & Johnson in 2004.

Executive Administrative Assistant to VP, Global & U.S. Marketing March 2000 – July 2001

Provided administrative support for the VP Global & US Marketing, managed department travel and coordinated the timely execution of interdepartmental tasks (i.e. legal agreements and marketing approvals).

EDUCATION

• San Jose City College – High School Diploma

• UCSF Medical Terminology Course

SKILLS

PhaseForward Data base, Microsoft Office (Word, Excel, PowerPoint and Access); CTMS; Internet

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