1. MARIA T. COULTON
_________________________________________________________________________________________________
110 Maple Avenue
Hatboro, Pennsylvania 19040
215.272.8669 (CELL)
mariatdonn@gmail.com
OBJECTIVE I choose to work in a collaborative team friendly environment where my talents and skills
will be fully utilized and where I will have opportunities to advance my career. I thrive on
challenges and pride myself on using the multi-tasking skills I possess on a daily basis. I
am an incredibly ‘quick learner’ and find this to be a very exciting and fulfilling quality I
possess!
EXPERIENCE
April 2015 – Present
TFS CRO Princeton, NJ
Senior Clinical Trial Assistant
Global Clinical Research
--Develop a working knowledge of project assigned protocols and all associated study
materials
--Develop a working knowledge of project assigned client contracts/scope of work
--Act as liaison between TFS/sponsor/sites/vendors throughout the life of the study
--Manage project “action logs” to ensure capture and follow-through on commitments
--made as part of project meetings, client meetings, and any similar venue
--Coordinate and oversee ‘study start up’ procedures including site identification and site
recruitment activities
--Request, review, process, and track requisite regulatory documents
--Develop project-specific forms, inclusive of forms required for regulatory binders
--Order, assemble, and ship study supplies, including regulatory binders to investigator
sites
--Manage printing, shipping, re-supply of Case Report Forms and transmittals with
vendors and CRAs
--Track the status of drug supplies at clinical sites and manage timely resupply of same
--Track patient enrollment at specified intervals and/or prepare enrollment graphs
--Track the monitoring visit trip reports and ensure all associated documents are submitted
to TFS
--Process investigator grant payments according to site contracts
--Maintain CTMS with current study specific data:
--Work with Sponsor to develop study specific reports in CTMS
--Create and deliver project reports using company intranet
--Compile study newsletters, presentations, and perform other tasks as assigned
--Prepare closeout visit site packets and process records/documents/supplies returned
from closeout visits
--Attend investigator meetings as required and participate in project team teleconferences
with sponsors and/or vendors
--Prepare agenda and meeting minutes for teleconferences and supply same to project
manager within 48 hours
--Maintain electronic calendar for all project associated meetings, teleconferences,
webinars
--Create and maintain project files (data management, clinical, sponsor)
--Transfer of central and site files to the sponsor at the end of the study
--Order and maintain project supplies
--Implement projects/initiatives as assigned by the Project Manager
--Provide support on special assignments within the project scope (e.g., SMC / DSMB
coordinator)
--Provide Business Development support as required (e.g., bid defense, capabilities
presentation, feasibility research and reports)

2. March 2010 – April 2015
PRA Health Sciences
CONTRACTED WITH JOHNSON AND JOHNSON GCO FT. WASHINGTON, PA
CLINICAL TRIAL ASSISTANT
GLOBAL CLINICAL OPERATIONS
--Generate and maintain databases for appropriate study administration
--Prepare and keep the Master File and Study Centre Files including all GCP-related
documents
--Administer all study and related documents before and during the course of the study
--Support 29 IDA’s as well as CRA’s and project managers in all relevant activities
--Assist Project manager, IDA’s, CRA’s in preparing project status reports for clients
--Manages all Mass Mailings for IDA’s
--Provide project support to the IDA’s, CRA’s and project managers
--Point of contact for JNJ related issues concerning IDA studies and the supplies needed
to get the study documents to the sites
--Federal Express Administrator for RPS
--Enter Data pertinent to IFDF and 1572 in CTMS and eTMF
--Follow up with sites on feasibility participation
--Provide regulatory documents to sites
--Coordinate all Sponsor Company monthly meetings
--CTMS Entry of new sites and ongoing information
--eTMF Uploading and reviewing
--Assist Project Manager as required to ensure the successful completion of the study
--File and Audit all study-related documents
--Track and maintain an updated report for all incoming invoices for Pass-Through Costs
--Contact sites as rquested by the Project Manager and distribute study related
information to the Regional CRA’s.
--Prepare study material at client meetings
--Track costs of supplies and vendors versus client contract
--Submit final monitoring trip reports to the Regulatory Department for filing
October 2008 – December 2009
REGISTRAT-MAPI BERWYN, PA
MARKETING AND ADMINISTRATIVE SUPPORT COORDINATOR
CORPORATE DEVELOPMENT
--Support of Business Development Group and Corporate Development
--Responsible for all presentations to new clients
--Report directly to VP of Corporate Development
--Coordination of all conference meetings offsite
--Responsible for all coordination of flights, hotel reservations for executive management
--Office Manager of Berwyn office
--Facilities management at office
--Point person for all and any activities going on in office
--Scheduling of all conference calls with clients and executives
--CPMN program administrator working with Program Director on a daily basis
--Event coordinator for all offsite meetings
--Take all minutes regarding any meetings and/or client conferences
--Coordination of any office maintenance to be done with regards to company merger
--Generated all daily schedules concerning conference booth
--Worked with display company to make new displays for conferences
--Daily communication with corporate office on what can be done to better serve the client
on study related issues
--Weekly staff meetings with Human Resource department
--Contributed to quarterly newsletter on events happening in Berwyn office

3. MAY 2007 – OCTOBER 2007
PREMIER RESEARCH GROUP HORSHAM, PA
(FORMERLY SCIREX CORPORATION)
SCIENTIFIC AFFAIRS EXECUTIVE ASSISTANT
FOR CHIEF SCIENTIFIC OFFICER/ VP OF SCIENTIFIC AFFAIRS
--Responsible for all travel arrangements for Scientific Affairs Group
--Populating tables for VP regarding the statistics on each study
--Reviewing protocols and determining CSO role
--Updating CSO on RFP’s requested and what is needed by our department to include in
proposal and bid defense
--Set up meetings through Microsoft office calendar and inviting numbers of attendees for
NICHD meetings/Teleconference with all clients-ie. Pharmaceutical companies (sponsors)
and any outside resources
--Interview candidates for Associate SA positions – first screener advising if they are a
good fit for our needs before the CSO interviews
--Generate all expense reports / any monthly reports showing progress of SA Group and
its effect on the proposals/bids our company won
--Setting up all internal conference calls for group this would include all international
offices involved in particular study we are working on
--Preparing for audits by pharmaceutical companies
--Updating all Sr. Management on the outcome of meetings/conference calls with our
sponsors/clients that they feel need improvement regarding moving forward on any
current study related issues
--Following through with any group or sponsor concerns and making sure their issues are
addressed by our staff and communicated to client/sponsor
--Working with all administrative support in company setting up for sponsor visits and
delegating assignments so that the visits are a success
--Daily reports to CSO with regards to all happenings of the day due to extensive travel –
receive advice on how to resolve and to move forward
DECEMBER 2006 – MAY 2007
PREMIER RESEARCH GROUP
(FORMERLY SCIREX CORPORATION)
EXECUTIVE ADMINISTRATOR
FOR VP OF US OPERATIONS/GENERAL MANAGER OF PREMIER
--First point of contact for the Horsham branch
--Supervisor for all administrative assistants
--Experience using Quick Books, Microsoft Office, Visio, Company created software
--Making sure all Sr. Management have updated list of daily incoming RFP’s
--Create and distribute quarterly charts of all departments to VP, regarding progress
(WINS/LOSSES/CHALLENGES). Departments to include Contracts/Proposals, US Sales,
EU Sales, Marketing, Business Development, etc.
--Create proposals; handouts; marketing material for BD department for client submission
--Generating lists of incomplete SOP’s for each employee whom have yet to complete
their training—following up to ensure completion
--Performing all aspects of organizing global management meetings including, hotel
arrangements, flights for international management as well as coordinating dinner events
for the managers during this meeting—catering luncheons for team—making sure all EU
management while visiting for the global meeting have all their hotel, travel, and daily
itineraries in hand
--Quarterly meeting agendas with speaker’s times all coordinated down to the minute
--Creating huge presentations for global meetings for numerous members including all
metrics and US progress of all departments which included numerous Power Point
presentations
--Have displays in boardroom up and ready for presentations
-- VP’s expense reports (as well as any Sr. Management needing support)
--On call for VP/Company when hosting visits from Sponsors/Clients/HR Fairs

4. --Coordinating first ever office ‘CLEANING YOUR SPACE—CREATING SUCCESS’ –
catered event for the office – proposed and won new office layout and design ultimately
concluding in a more user friendly area and flow for daily work environment
JULY 2006 – DECEMBER 2006
PREMIER RESEARCH GROUP
(FORMERLY SCIREX CORPORATION)
MEDICAL AFFAIRS SPECIALIST
MEDICAL MANAGEMENT AND SAFETY GROUP OF PREMIER
--Review EVERY AND ALL labs sent to the office for direction on how to handle
--Alert the safety officer of any irregular ranges along with calling the sites to be sure they
are aware of the particular patient and their values
--Letting the different sites know if a patient is allowed to participate/continue in the
ongoing study given their (baseline) results
--Creating SAE reports from the information provided including lab values then distribute
to the project manager and her team
--Entering all SAE information on an SAE spreadsheet regarding the progress of that
individual then following up for missing information (contacting participating sites)
--Calling sites when they are in violation of HIPAA, explaining the patient in jeopardy and
the violation they have committed; following up with written warnings
--Meeting with the safety officer and her group once a week for group updates; issues of
most importance to be followed up on immediately; discussing how we can better avoid
client issues and concerns
--Working with the archivist to determine if study related documents are needed to be sent
to the sponsor or if needed to be stored depending on what our client prefers
--Creating a tracking system for each study to include a file for each patient participating,
their site reporting to with all information needed to contact their study coordinator, also
including a place for any SAE’s that may occur for easy access as well
--On calls related to any issues the sponsor may have about certain SAE’s and whether it
is deemed a true SAE then following up with required paperwork
--Created an Excel spreadsheet used by Saftey Officers and Medical Management for
weekly teleconferences updating all on current SAE’s and their outcomes
NOVEMBER 2005 – JULY 2006
PREMIER RESEARCH GROUP
(FORMERLY SCIREX CORPORATION)
EXECUTIVE ASSISTANT
VICE PRESIDENT OF CLINICAL OPERATIONS/MEDICAL MANAGEMENT & SAFETY
GROUP AND CORPORATE VP SCIENCE AND RESEARCH
--Oversee Medical Mgmt Group and Safety Group (supervisory position) in V/P’s absence
--Point of contact daily for all MM&S issues, run office independently due to VP’s
continuing travel
--Responsible for keeping calendar updated with all events, meetings, travel
--Make all travel arrangements when traveling in US and Europe
--Schedule and interview potential candidates for upcoming safety positions
--Coordinate all teleconferences with staff and offices across US
--Generate all expenses for both VP’s as well as members in safety group
--Prepare and schedule departments bi-weekly meetings along with disbursing agenda
--Compile minutes from meetings and distribute accordingly with regards to departmental
updates and new procedures beginning
--On call 24 hours for SAE alerts---needing to contact medical monitors of all issues
--Enter all drug and patient information on to SAE database
--Weekly meetings with all company assistants to see how I can better help them do their
day to day tasks as well as special project assignments
--All facets of VP’s needs with regards to any clients, meetings, teleconferences, out of
country conferences taking place – coordinate and make sure all dinners, luncheons,
meet-n-greets are adequately catered and arranged

5. --Work with Human Resource department making sure potential candidates complete all
forms and screen them prior to meeting senior management to decide if good fit or not.
--Compile spreadsheets of all active studies that medical management & safety are
responsible for and must keep updated daily for distribution
--Produce ideas for Sr. Management to better streamline work of admins, not to duplicate
procedures but to utilize time in a better more efficient manner
--Event coordinator with regards to breakfasts/luncheons/dinners for clients and senior
management
JULY 2001 – NOVEMBER 2005
MONITOR FOR HIRE.COM CONSHOHOCKEN, PA
SENIOR OPERATIONS ADMINISTRATOR
--Responsible for day to day operations within both of our Corporate offices in PA and CA
--Screen, approve, and train all monitors seeking affiliation with our community...
--Established and maintained new guidelines for background verification of all prospective
CRA’s
--Supported all Business Development Team coordinated any meetings with clients or
MFH Executives needed, expenses, trouble shooting, client intervention
--Generated all financial data for clients and officers of MFH, including all invoicing,
account management, statements, profit and loss, collections, as well as sales analysis
working with Quick Books, Microsoft Office.
--Developed and maintained relationships with clients of all aspects (sponsors, CRO’s,
monitors)
--Invested significant time building strong relationships with accounts payable departments
of our client companies and maintain close communication regarding on time payments.
--Liaison between all clients and monitors for all invoicing, training and billing.
--Reviewed benefits, payroll, and MFH company policy with all new employees of MFH to
make them comfortable and welcome.
--Editor of company newsletter including research of all articles published and collaborate
with our media company to design the layout and time of distribution on a quarterly basis
--Worked quarterly with company accountant on financials
--My sense of humor added balance and levity to our work environment-which I strongly
believe created a place to come to work and tackle any challenges the day brought!
***Recognized for achieving an all time low of less than 5 % of receivables past 30 days or
more***(the company has never seen this since its establishment)
JANUARY 2001 -- JULY 2001
MONITOR FOR HIRE.COM
ADMINISTRATIVE ASSISTANT
--VP of first impressions (first contact with all clients, monitors, vendors)
--Schedule all appointments between CEO and client meetings
--Liaison between Sponsor company/CRO and MFH resulting in a more user friendly
website
--Schedule all out of town reservations for client visits, hotel, travel, etc.
--Generate all packet and presentation binders for business development
--Review, approve, and process monitor payroll documentation.
--Process all incoming and outgoing mail on a daily basis.
EDUCATION
BUCKS COUNTY COMMUNITY COLLEGE NEWTOWN, PA
--Criminal Justice
--4.0 GPA
--Letter of recognition from Senator Greenwood for
Outstanding Achievements by Working Mothers
ARCHBISHOP HIGH SCHOOL FOR GIRLS WARMINSTER, PA

6. --Majored in business administration
--Top honors in English all four years
--Recognized for outstanding attendance for two years
REFERENCES AS WELL AS LETTERS OF RECOMMENDATION AVAILABLE UPON REQUEST

7. --Majored in business administration
--Top honors in English all four years
--Recognized for outstanding attendance for two years
REFERENCES AS WELL AS LETTERS OF RECOMMENDATION AVAILABLE UPON REQUEST