Project Manager Staff

Meryl P. Poland

Montgomery Village, MD

240-***-****

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

Career Summary

Seasoned Clinical Trial Coordinator and Document Specialist with history of

creating new ideas and implementing processes resulting in improved flow

of studies bringing trial to successful conclusion.

Professional Experience

Owner/Consultant, Creative Innerscapes - Montgomery Village, MD

January 2013 - Present

. Organize and de-clutter spaces consistently resulting in maximum

organization of home or office

. Staging of homes for sale which helped to enhance the home to make it

more saleable

. Developed ideas for repurposing items already available ultimately

resulting in significant cost savings for each client

Clinical Data Manager, Leidos (contract) - Rockville, MD

April 2012 - December 2012

. Engaged in detailed examination of electronic case report forms for

accuracy. Independently identified conflicting information resulting

in query generated for Study Site personnel resolution

. Accurately applied new data requirements and checks thereby, verifying

validity parameters.

. Accurately extrapolated data in order to prepare information for

presentation to National Cancer Institute.

. Independently prepared updates to site level regulatory binders for

Ethics department. Created spreadsheets to capture regulatory and

site documentation

.

Document Specialist III, MedImmune - Gaithersburg, MD

September 2011 -July 2012

. Maintained all details of Trial Master File in accordance with

applicable regulations, policies and procedures with exceptionally

high rate of accuracy

. Mentored Document Specialists I/II and contract staff. Staff learned

processes quickly, accurately and successfully

. Created improved processes and procedural controls enabling the

personnel to easily access TMF

Senior Project Coordinator, Global Research Services - Rockville, MD

September 2009 - June 2011

. Proposed and implemented improvements to existing processes, revisions

and Standard Operating Procedures, resulting in significant

clarification for clients

. Provided overview of study timelines and resource needs, ensuring

fluid and accurate operation of the project

. Efficiently coordinated trial-specific meetings and trainings

. Tracked, collected and prepared regulatory packets regulatory for

submission to Institutional Review Board.

. Created and maintained TMFs for sponsors

Project Manager, Fisher BioServices - Rockville, MD

June 2007 - September 2009

. Managed and coordinated all aspects of project, from start-up through

completion

. Evaluated projects, interacted and negotiated with outside vendors and

subcontractors to secure needed components or services in order to

move a project to successful completion

. Developed SOPs and/or business rules for the implementation of new

programs

. Assisted with client audits and resolution of discrepancies

. Developed templates for accurate use of batch and production records

for packaging and labeling activities

. Price build-Ups and quotes for biorepository services for new and

existing clients

Study Protocol Manager, The EMMES Corporation - Rockville, MD

November 2005 - May 2007

. Responsible for managing ophthalmic protocols for government (NIES)

and industry

. Conducted in-house and on-site monitoring for studies

. Liaised with NIH/NEIS, FDA and the IRB

. Participated/facilitated Retina Operation Meetings at National Eye

Institute

Clinical Research Study Coordinator, (contract) NIH (NINDS) - Bethesda, MD

February 2004 - October 2005

. Organized, screened and recruited specific patient populations for

client per protocol.

. Prepared, organized and maintained study and source documents in

accordance with FDA regulations, ICH/GCP and SOP guidelines. Reviewed

and maintained study regulatory binders and databases.

. Acted as liaison between physicians, nurses and patients for study

related activities

. Prepared and submitted regulatory documents to IRB.

. Tracked and recorded all Adverse Events (AE) and Serious Adverse

Events(SAE)

Publications:

"Quantitative Dysmorphology Assessment in Fabry Disease"; Genetics

in Medicine, February 2006

Jackson Heart Study protocol; February 2001

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