Custom

January 2007 - Global Pharmaceutical Research and Development President's Award for contributions to the Humira Ankylosing Spondylitis US/EU Submission/Approval project merit that kind of recognition.

December 2005 - ImmunoScience Award - Contributions that significantly exceeded normal job scope and expectations for the implementation of eRoom.

September 2005 - ImmunoScience Award - Contributions that significantly exceeded normal job scope and expectations for the development and implementation of the Master Trial File Database.

February 2005 - Spot Award - recognition of my contributions, which exceeded normal job scope and expectations for a clean audit of the finance department.

Objective

To obtain a position that will enable me to utilize my strong organizational skills, educational background, and ability to work well with people in the Pharmaceutical Industry.

Summary

Worked in the Pharmaceutical Industry for 6 1/2 years from the accounting department to a CRA. I am looking to obtain a position that will enable me to utilize my strong organizations skills, educational background, and ability to work well with people.

Work History

Work History
Feb 2007 - Present

Manager (Home Business)

Echo Hill Studios, Inc.
⁃ Manage client accounts ⁃ Marketing ⁃ Accounts Payable and Accounts Receivables ⁃ Advertising ⁃ Deal with clients on a one-to-one basis with bookings ⁃ Update Website Design through WebDesign Software ⁃ Generate Weekly and Monthly Sales Reports ⁃ Customer interaction on the telephone and in person
Sep 2005 - Feb 2007

Clinical Research Assistant

⁃ Manage CROs (i.e., Review monitoring schedule for expected windows, clinical supply management, review monitoring reports/track monitoring reports, day to day site issues/communications, assist in monitoring of clinical study sites (source document verification, drug accountability, review of essential documents, audit of submission of IND safety reports.), data review to include query/addenda process and assist in preparation of clinical study reports.) ⁃ Assure additional supplies are ordered as needed. ⁃ Develop and distribute quarterly newsletter to investigator sites. ⁃ Update study logs and present site status at weekly meetings ⁃ Work with data management regarding listing reviews, database locks, and query tracking. ⁃ Track Study drug shipments and update study progress. ⁃ Track and distribute safety letters to all investigative sites ⁃ Review and verify IND safety reports are reported to the IRB. ⁃ Format documents to be scanned into eSubs, review and approve documentation for CSE, CSS, and other submissions to the FDA. ⁃ Assisted in study startup activities: CRF design, coordination/preparation of protocols, informed consents organize and track the list of potential study sites interested in the program and assist in the logistics of the selection process, assist with the development of meeting materials and logistics for investigator meetings, assist with the development of reference tools for the site reference binder, pharmacy binder, and non-clinical supplies needed for the site initiation, assist in the review of essential documents prior to release of drug at the sites, assist in developing an investigator grant/payment spreadsheet for the protocol and work with contracts group to ensure contracts/budgets are sent to the sites within the specified timeframe. ⁃ Update Investigator Brochure on yearly basis. ⁃ Multiple database experience
Nov 2004 - Dec 2005

Clinical Research Administrator

• Provide administrative support for Project Managers in Clinical Research Department. • Receipt, distribution and disposition of all incoming mail, including: Correspondence, invoices, requests for study supplies, etc. • Receipt, copying and preparation for Central Files of all incoming regulatory documentation (i.e., updated 1572 forms, CVs, amendments, etc.). • Created and maintaining Access Database for Regulatory Tracking. • Preparation and tracking of study payments for investigators. • Preparation and tracking of vendor payments (i.e., Phase Forward, CRO, Labs, etc.). • Preparation and tracking of contract CRA expense and time payments. • Arranged travel requirements for small groups. • Calculated travel expenses and entered Expense Reporting into Expense Link program. • Tracked TIME reporting and entered into R-TIME for group. • Sort and triage mail to appropriate departments while responding to questions within my realm of knowledge. • Arranged on-site training course that included airline needs, local transportation, lodging and entertainment needs. • Received training certification for Phase Forward Internet Software, SAE Reporting, FDA Preparedness Training, Essential Document Training and SOP and GCP Training. • Skill and proficiency in the use of MS Office, Lotus Notes Mail & Scheduler, conference Room Scheduler, RSYS, R-time, PPS System, CAS System, Optika, XMS, Phase Forward InForm, and Expense Link.
Oct 2002 - Nov 2004

Accounting Clerk

• Finance Department invoice reconciliation and check request preparation • Set-up accounts and provide training and user support for ISDC Financial Systems (CAS, Mercury, XMS, Optika, PPS, R-TIME Database) • Disseminates new systems and system changes to appropriate ISDC staff in a manner that contributes to positive acceptance of a changing environment. • Audits and processes check requests for all of ISDC to insure adherence to Financial Policies and timely payment. (3,900 per year) • Key contact with vendors for resolving accounts payable related problems. • Set-up and maintain ISDC employees in the RTIME system. • Set-up and maintain ISDC Floor Plans, Move Database, & Phone List • Assist in developing and maintaining various financial databases. • Performs audits of Purchasing Card Transactions. (6 audits 12 times per year) • Reviews Travel Advance Report and investigates old items and helps ISDC staff resolve old items. • Create and design graphical presentations as needed.
Sep 2000 - Oct 2002

Clinical Research Administrator

• Provide administrative support for Project Managers in Clinical Research Department. • Receipt, distribution and disposition of all incoming mail, including • Correspondence, invoices, requests for study supplies, etc. • Receipt, copying and preparation for Central Files of all incoming regulatory documentation (i.e., updated 1572 forms, CVs, amendments, etc.). • Created and maintaining Access Database for Regulatory Tracking. • Preparation and tracking of study payments for investigators. • Preparation and tracking of vendor payments (i.e., Phase Forward, CRL Labs, MDS Harris Labs, etc.). • Preparation and tracking of contract CRA expense and time payments. • Arranged travel requirements for small groups. • Calculated travel expenses and entered Expense Reporting into Expense Link program. • Tracked TIME reporting and entered into R-TIME for group. • Sort and triage mail to appropriate departments while responding to questions within my realm of knowledge. • Arranged on-site training course that included airline needs, local transportation, lodging and entertainment needs. • Received training certification for Phase Forward Internet Software, SAE Reporting, FDA Preparedness Training, Essential Document Training and SOP and GCP Training. • Skill and proficiency in the use of MS Office, Lotus Notes Mail & Scheduler, conference Room Scheduler, RSYS, R-time, PPS System, CAS System, Optika, XMS, Phase Forward InForm, and Expense Link.

Education

Education
1978 - 1980

Business Management

1972 - 1977

General

Byram Hills High School

Skills

Skills

Microsoft Office

November 1998 Microsoft Excel Advanced Course Sussex County Community College Newton, New Jersey   January 2003 Microsoft Access (Intermediate/Advance Course) New Horizons Parsippany, New Jersey   September 2005 Microsoft Access 2000 (Intermediate/Advance Course) Skillpath Parsippany, New Jersey   November 2006 Microsoft Project Intermediate Course New Horizons Parsippany, New Jersey