Administrative Assistant Project

Anne H. Cucinotta

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

Flemington, NJ 08822

908-***-**** (ph) 908-***-**** (c)

Email: acd3xg@r.postjobfree.com

WORK HISTORY

CFS Clinical (Yoh) Audubon, PA (2/14 -

Present)

Clinical Contracts /Project Specialist

. Prepare new study contracts into our study trackers.

. Negotiate and review contracts and budgets with sites.

. Set up PO's and oversee entire process.

. Manage documents sent to site/sponsors.

. Resolve outstanding issues with contracts/budgets.

. Enter agreements and budget contracts into our Sales Force Apttus

System

Novo Nordisk (Inventiv Health) Princeton NJ,

(11/13 - 12/13)

Clinical Business Suport Coordinator (Hemophilia Area)

. Prepare contract study trackers for new studies.

. Track contracts in excel database tracker.

. Work on site budgets and counter offers for proposals with sites.

. Input information in iMedia Data and Clin tracks for sites.

. Distribute MCTA, appendices, and W-9 Form to sites for review.

. Manager contract in boxes, reply or reroute emails to team members.

. Meet with Bio Pharm and Endocrine personnel on a weekly basis to

strategize and organize work load.

. Regular follow-up with sites.

. Finalize approved relined Master Clinical Trial Agreements and

appendices.

. Work on site contracts and following through until execution.

. Work closely with CBM site negotiators and keep team informed on

status/changes as they occur.

Amarin (Inventiv Health) Bedminster NJ, (9/13

-11/13)

Clinical Project Associate

. Heavily involved with preparation of FDA audit and worked closely with

Senior Manager of Clinical Development while FDA was ongoing for

several weeks.

. Review and assist in process with SOPs incoming SAE forms

. Set-up, populate and maintain the clinical trial monitoring/management

grant tracking systems.

. Follow-up on data inquires and generate reports.

. Worked on weekly enrollment trackers/ site issues.

. Involved with Financial Disclosure forms

. Worked closely with our CRO on our monthly study newsletter and

impliment changes and ensuring newsletter was sent out on time.

. Responsible for sending out contract agreements and working closing

with our legal team.

. Maintenance of project specific regulatoy documents for inventory

system.

. Work on ensure system and TMF documents.

Merck (Sunrise Systems) North Wales, PA

(10/12 - 3/13)

Global Study & Site Budget Specialist (Therapeutic Area- Epidemiology)

. Create a budget plan and negotiate legal review for neuroscience

studies.

. Provide specialized support and assist physicians and GSSBS in the

planning, execution and control of all global clinical grant

financial functions.

. Worked with MS Project 2010 and helped develop Gantt charts on

tasks, milestones, summary tasks and timelines. I was responsible

for following projects and making sure the projects met there

timelines.

. Ran filters and reports and had weekly meetings with my manager on

the progress of the reports.

. Coordination and management of project meetings. Also was involved

with taking and maintaining minutes pertaining to the meeting.

. Involved in planning, negotiating and administration, outsourcing,

procurement and legal review of clinical study programs.

. Facilitate global clinical grant financial administration as well

as evaluate and reports to GSSBS financial group.

. Code and process all invoices to the accounts payable department.

. Post all clinical trial agreements to the e-Room.

Sanofi (RPS) Bridgewater, NJ (1/12 -

10/12)

Clinical Project Associate (Therapeutic Area-Oncology/Diabetes)

. Set-up, populate and maintain the clinical trail

monitoring/management grant tracking systems.

. Review and assist in the process with SOPs incoming SAE forms.

. Follow-up on data inquires and generate reports.

. Work on Impact, Access, and update information on e-room.

. Re-order and assist with drug shipment supplies for clinical

trials.

. Prepare investigator grant payment requests and corresponding

cover letters for distribution.

. Generate reports on status of grant payments and resolves payment

inquires from investigator sites.

. Distribute IND Safety letters to investigators and track and

follow up on correspondences.

. Maintenance of project specific regulatory documents for inventory

system.

Johnson & Johnson (Kelly Services) Bridgewater, NJ

(5/10 - 12/11)

Clinical Trial Assistant (All Therapeutic Areas)

. Supports Clinical Operations Management Team and Associate

Director.

. Coordinate off-site meetings.

. Assist in Adverse Event Reports to investigator sites and central

IRB's.

. Assist in general filing of clinical trial documents and

occasional auditing of investigator files for most up to date

versions of documents.

. Mail out Investigator Brochure Addendums and Informed Consult

Addendums on various protocols.

. Handle 1572 documents for uploading into ERIS.

. Follow up on phone calls on Clinical Trial Disclosure Agreements

to sure institution has received documents and will sign and mail

back before deadline.

. Trains and mentors new CTAs-PS in department procedures and project

specific tasks.

. Create and maintains investigator contact list.

. Prepares and generates correspondence to investigators or site,

vendors, and internal mailing.

. Handles archiving of Trial Master Files (CAF or LAF) and

electronically shared drives.

. Coordinates all activities associated with the Clinical Management

Team in US Clinical Trials rollout, including local investigator

meetings for specific programs.

. Responsible for coordinating HR interviews for candidates.

. Handle on boarding forms for candidates and responsible for setting up

new hires into the system along with filling out forms for employees

that have been terminated.

Novartis (Aerotek)

Florham Park, NJ (11/09 - 5/10)

Project Coordinator

. Support Executive Director in addition to 14 members of the

department.

. Work with team on Clinical Development Phase 2-3 Projects.

. Compose correspondence/memos in the highest confidential manner.

. Sent out confidentially agreements for various projects.

. Manage both global and domestic travel arrangements.

. Set up meeting requests for 15 members of the department.

. Expedite monthly expense reports for several members of the

department.

. Coordinate internal/external meetings, videos and conference calls.

. Assist in the development of slide presentations.

. Handle confidential information and communication with all levels of

management in a professional manner.

Novo Nordisk, Inc. (Kelly Services)

Princeton, NJ (4/09 - 8/09)

Project Coordinator

. Arranged business meeting registrations, travel and hotel

accommodations.

. Compiled budget reports from SAP system for monitoring monthly

spending vs. budget.

. Completed check request forms, reviews and process invoices.

. Scheduled meetings for various groups and coordinate refreshments.

. Prepared power point presentations for meetings.

. Managed charges of T&E expenses for department.

. Organized and prepared contract agreement letters and followed up on

all documentation.

Sanofi-Aventis Pharmaceuticals (Bryant Staffing)

Bridgewater, NJ (8/05 - 2/07)

Grant Coordinator (Therapeutic Area-Oncology)

. Managed TAGC weekly meetings and SAGC Monthly meetings.

. Prepared agendas and distribute minutes.

. Organized and prepare materials for distribution.

. Maintained an accurate website throughout the grant process.

. Communicated with grant requestors to ensure a smooth grant process.

. Worked with National Education Managers to discuss outcome of grants.

. Prepared, track and ensure that all required signatures are attained

on all Electronic Contract Agreement Forms/Sanofi Aventis Grant

Agreements.

. Handled all grants over $50K to ensure signature is followed through

to finance in compliance with grant.

. Managed all hotline phone calls from customers to make sure any of

their questions are answered in an accurate and timely manner.

. Prepared and manage closeout files for all assigned grants in

compliance with sanofi-aventis regulatory guidelines.

. Managed check request and mail to requestors, track approval process

and sign offs.

. Mailed out fully executed grant agreement to requestors.

. Tracked invoices with accounts payable to resolve payment and process

issues, quarterly accruals, and interface with vendors as needed.

Aventis

Bridgewater, NJ (4/01-2/05)

Senior Administrative Assistant

. Supported Head of Clinical Operations and Evidence Based Medicine &

Operational Support Departments.

. Created and forecasted budget reports to finance department for the

upcoming year.

. Coded all department bills for payment.

. Maintained excel spreadsheets for various projects and created

PowerPoint presentations.

. Organized achievements of department and prepared reports to VP of

Medical Affairs.

. Handled travel arrangements for the department.

. Organized weekly meetings for groups as large as 25 people.

SIG Plastics Technologies (USA) Inc.,

North Branch, NJ (7/00 - 3/01)

Executive Administrative Assistant

. Handled all travel arrangements for the President, Vice President and

other members of my department.

. Composed sales letters and distribute media kits to various clients.

Work on sales quotations for clients and diversified projects using

excel.

. Submitted weekly expenses and service reports for submission to the

accounting department. Work very closely with President, and Vice

President of our division.

. Maintained Project List and delegated to outer offices.

EDUCATION:

Somerset County Vocational Technical School, Bridgewater, NJ

Medical Billing & Coding - Graduated

Sullivan County Community College, Loch Sheldrake, NY some college

coursework completed

RVCC pursuing an Associate's Degree in Humanities and Liberal Arts and

working on my Bachelors

Notary Public

Computer Software Skills

Proficient in Word, Excel, Power Point, Outlook, Lotus Notes, Ariba,

Internet Explorer & SAP, Visio, Eris,

eTMF, Share point, GXRS, CTSRS, Access, Impact, Catalyst, Microsoft

Project, ensure, iMedia Data, Clin Track.

Contact this candidate