Customer Service Project

Sandra S. Schemelia

* *********** ***** *****, ** 08638 H: 609-***-**** C: 609-***-****

*********@***.***

Clinical Project Administrator

Clinical Project Administrator with extensive experience in overseeing

research projects, and participating in planning and executing various

research projects. Knowledge in supporting next-generation database.

Proficient in an assortment of technologies, including Oracle, Access,

Trial Master File, Right Track, Windows (complete list on request). Skills

include:

Maintaining weekly technology reports Maintain Trial Master File

with First Class Software Setup and maintain Investigator Site

Operating system files comprising an Files

Oracle database Updating and requesting information

Knowledge of Microsoft Applications with SQL

Experience

Regulatory Assistant, Bridgewater, NJ

5/2013 - 7/2013

ReSearch Pharmaceutical Services

Maintain regulatory documents for on average of 75 active studies

Process study start-up packets for green-lighted sites

Process FDA 1572 document to Clindocreg before submission to the FDA

Ensure regulatory documents for site and general files are filed within a 15

day turnaround time

Maintain the Local Study File room

Assist with maintaining the Adverse Event safety reports, the weekly IND

reports and the Dear Investigator letters

Keep track of documents submitted for potential/dropped sites

Assist with preparing for internal and external audits

Assist with archiving closed studies

Train new hires with LSF procedures, SOP's, protocols and departmental

policies.

Keep up-to-date with all Sanofi & RPS required SOP's

Covance, Princeton, NJ

3/2011-5/2013

Senior Clinical Project Administrator

. Assisted and prepared in the Covance Project Experience-Otuska AWARE-

Tourettes

1. Worked on the Genentech GDC4950g FERGI Breast Cancer Study

2. Prepared study related documents and other material for delivery to

archives..

. Set up and maintain documentation for Trial Master Files and clinical

investigator files

. Prepare study-related documents and other materials for delivery to

archives, at appropriate intervals

. Work with various data to ensure information is properly tracked

. Organize/prepare for client meetings/teleconferences

. Assist/prepare for client or internal audits

. Uploaded various documents to Trial Tracker - Lotus Notes

Pharmanet Development Group, Princeton 2/2009 -

3/2011

Technical Assistant

Developed functional, scripts and reports that were

instrumental to the success of high-priority developmental project.

3. Developed IIP Packets to approved sites for new studies.

4. Assisted and prepared Pfizer and Shire approved Protocol.

5. Updating data on a weekly and monthly basis using Right Track-Pfizer

system and Promis-Pharmanet system.

6. Created and maintained Trial Master Files and setup and maintained

Investigator Site Files.

7. Worked on the Pharmanet Project Experience-Phase 3-Osteoporosis

(Pfizer Study)

8. Contact study personnel at sites regarding administrative issues

. Order office supplies as needed by project team

1. Generate and maintain study-specific tracking spreadsheets (e.g.

patient enrolment, regulatory documents, site visits, investigator

payments)

2. Ship/mail supplies and documents to clients and investigator sites

3. Assist in assembling materials for Investigators' Meetings

4. Maintain Investigator payment documentation

5. Generate and maintain study-specific tracking spread sheets

Apple One, Trenton, NJ 10/2008 - 1/2009

Working as a Temp for the Hibbert

Group

. Prepare daily reports using Excel and Access databases

. Process daily fulfillments of for McKesson

. Handle various request for shipping files and expedite orders

. Attend weekly staff and team meetings

St. Charles Borromeo Church, Skillman, NJ 6/2004

-7/2008

Administrative Assistant

. Handle multiple tasks within the educational department

. Set up and maintain the access database

. Communicate efficiently with all staff to ensure various tasks are

completed on time

. Prepare booklets, registration and information for 1st-8th CCD

students

. Provide excellent customer service support to the church community

. Work independently or as part of a team to meet departmental goals for

the parish.

Hopewell Valley Regional Schools, Pennington, NJ

7/2002 -5/2003

Secretary for Technology Department

. Maintained the weekly technology report using the First Class Software

. Used software program called EMAP to enter purchase orders

. Reviewed yearly budget and continuously update by using

Excel

. Ordered supplies via phone for technology department

Union County ETTC, Scotch Plains, NJ

1/2000 -6/2001

Computer Trainer

. Trained personnel how to utilize new software applications to benefit

their classrooms to run more efficiently

. Developed materials to educate teachers, administrators and

secretaries on various software applications

. Researched various educational websites for the teachers and staff to

implement into the classrooms.

. Oversaw suggested software for future workshops

Education

Thomas Edison State College, Trenton, NJ

Bachelor of Arts, Major in Liberal Arts

Microsoft Certified Technology Specialist

Mercer County Community College, West Windsor, NJ

Associates Degree in Applied Science

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