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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.

References

Becky Yanas

“worked directly with you “It is my pleasure to recommend Janine Wilson, her performance working as a Clinical Research Assistant for Abbott Laboratories proved that she will be a valuable addition to any company. I have known Janine for 8 years in my capacity as Payment Specialist at Abbott Laboratories. Janine worked with me on various clinical trials as a Clinical Research Assistant, and based on her work, I would rank her as one of the best Clinical Research Assistant we have ever had. She takes her work very seriously and was great at troubleshooting issues. She works very well under stress and will devote overtime as needed.”” June 23, 2009

Bob Wong, MD

“May 6, 2009 I am a rheumatologist in wsas in charge of the Humira Ankylosing Spondylitis Clinical Subteam at Abott Laboratories. I have known Janine Wilson since 2004 when she joined the Humira (adalimumab) Ankylosing Spondylitis (AS) Clinical Subteam as a Clinical Document Specialist; she was in charge of managing relevant clinical documents (eg reports, etc.) related to this program. Subsequently, due to her excellent high quality work and team orientation, she was promoted to the Clinical Research Assistant position, assisting the Senior CRA and other team members on the program. She possesses excellent technical computer skills which were important in creating and maintaining a publication archive (realted to AS), and also creating documents that were important for the successful Humira AS registraion and approval. Please call me at (908)-630-9614 if there are any questions. Robert Wong, MD” May 6, 2009

Larry Hart

Top qualities: Great Results, Personable, High Integrity

“Janine is not only a pleasure to work with, but she brings an excellent mix of personal and professional attributes to any situation. She goes far beyond the typical service provider approach. She becomes a close and trusted friend, who then takes a sincere interest in every production element I need, regardless of the size of the project. We work in a business environment which often requires rapid turnaround, and regardless of what requests we make, the response is always the same. Fast. Professional. Superb. Janine is the consumate professional.” June 2, 2009

Jeff Meeks

“Janine was a self starter and always went above and beyond. She would find solutions to most problems on her own. She needed very little supervision. Over all Janine was an excellent employee.” June 3, 2009

Work experience

Feb 2007Present

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 2005Feb 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 2004Dec 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 2002Nov 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 2000Oct 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

19781980

Business Management

19721977

General

Byram Hills High School

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