Clinical Research Professional

Professional Summary Self-motivated, reliable clinical research professional with

fifteen year track record of providing operational support

for managing large scale global clinical programs for

pharmaceutical new drug development. Excellent knowledge of

complete aspects of the clinical trial management to ensure

compliance to research protocols. Experience in providing

assistance to monitoring trial operations and deliverables

from study start to Database lock. Proven ability to

research, extract and interpret research records. Complete

knowledge of GCP, ICH and FDA guidelines including basic

understanding of regulatory requirements. Focused with

excellent attention to details, decision making,

interpersonal and communication skills. Clinical expertise

in multiple therapy areas including: Respiratory, Diabetes,

Cardiovascular, Oncology, and Medical Devices.

Experience Medical Affairs Study Coordinator January 2013

- February 2015

Therakos, Inc. Bridgewater, NJ

Responsible for oversight of consulting agreements and

contracts by performing and managing all activities

associated with the drafting, negotiating, reviewing and

execution of clinical research agreements, Investigator

Initiated Studies, vendor contracts, confidentiality

agreements, consulting agreements, and amendments to support

the business needs of Therakos, Inc. Global Medical Affairs.

Serve as a liaison between cross functional internal and

external stakeholders for developing and changing scope of

work, contract language, terms and conditions. Assist with

negotiations for amendments and budget often requiring

proactive identification of issues, and using business

judgment for resolution and escalation as appropriate.

Grant coordination includes preparing grant request,

contracts, payments, tracking status and facilitating

committee meeting. Support activities for budget and

payment coordination to include submitting invoice and

tracking payment to Accounts Payable. Assist Trial Manager

with clinical supply tasks including ordering; obtain

regulatory signoff and tracking supply delivery. Perform

various administrative tasks including maintaining

electronic library, preparation of FMV assessment and log

and tracking medical information requests from institutions.

Clinical Trial Administrator

January 2012 -March 2012

Cmed Research New Providence, NJ

Administer, coordinate and support the clinical team with

the logistical aspects of clinical trials in compliance with

GCP and SOPs to include preparing and maintaining study

specific documentation, procedures, newsletter in accordance

with ethics and regulatory submissions. Perform primary

coordination of Investigator payments, ordering/dispatch and

tracking of trial materials and safety reports.

Administrative tasks comprised of organization of project

team and investigator meetings, preparing PowerPoint

presentation, and transcribing meeting minutes.

Clinical Trial Systems Specialist

March 2011-November 2011

ImClone Systems Bridgewater, NJ

Database setup, training and support for trial set up of

ImClone compounds in Eli Lilly's database requiring

collaboration with colleagues from both organizations.

Performed data entry for all ImClone trial/country and site

level data. Trained and provided support GCO staff on

appropriate use and access of IMPACT. Facilitated

transparent communications between IMPACT users during

ongoing trial execution, data integrity training, software

maintenance and, updates, and issues requiring escalation to

SMEs. Monitored drug request forms, drug shipment and

prepared TMF documents.

Operations Analyst/Contract Administrator June

2010- March 2011

Merck Research Laboratories (Consultant)

Assisted the Project Lead with tracking and management of

outside services contracts, grants and payments, ensuring

timely and accurate financial reports for outside research

services. Processed and managed the contractual agreements

and clinical/non-clinical grants by preparing grant payment

package and facilitated initial set-up in the Grant

Management system. Process for approval outside vendor

invoices for accuracy and compliance to the contract.

Conducted monthly/ quarterly budget status review.

Trial Management Associate

August 2009- June 2010

Merck Research Laboratories (Consultant)

Assisted in the management of clinical trial activities to

ensure compliance with the study protocol and overall

clinical study objectives. Generation of reports for

monitoring trial enrollment, site status data and number of

discontinued patients and reasons for discontinuation.

Managed daily site information via CTMS and Spectrum

systems. Maintained various trackers comprised of ClinDoc

Return Status Tracker, Amendment Trackers, and Temperature

Device Tracker. Reviewed monitoring reports for

completeness and accuracy. Administrative task included

execution of Trial Master File. Quality Control checks,

editing and proof reading training documentation, and

verifying IMP compliance for sites using the InForm data

base.

Clinical Research Assistant

December 2008-April 2009

Johnson & Johnson (Consultant)

Provide study start up support to Local Trial Manager.

Distributed and tracked investigator feasibility

questionnaires, checked investigator against FDA OAI and

debarment list. Reviewed site regulatory documents for

accuracy, initiated and tracked confidentiality agreements.

Processed informed consent approvals and coordinated central

IRB submissions. Communicated and liaison with site

personnel and site manager for document updates and

corrections to ensure study site readiness. Trial support

included maintenance of financial disclosure logs,

preparation of final trial master file documents, coordinate

site approval status for drug shipment, tracked SUA receipt

acknowledgment letters and under the supervision of the

Local Trial Manager, compiled information required for

completion of Appendix 1.4.1. Distributed final versions of

Investigator Brochure, and submission of documentation to be

imaged for electronic publishing

Clinical Project Administrator August 2007 -

December 2008

Novo Nordisk, Princeton, NJ

Assist in-house clinical project teams, field based CRAs,

Project Associates and Senior Clinical Project Manager by

performing various tasks during project start up, clinical

conduct, and closeout portions of drug development

activities. Preparation and review of regulatory documents

and confirmed IRB notification for the trial set-up and

maintenance in compliance to company SOPs and Federal

guidelines. Track trial-related documents i.e. CDAs,

Financial Disclosure, CRFs, ICFs, contracts, regulatory

documents and managed information in appropriate databases

ensuring study documents are filed in the Trial Master file

in accordance with SOPs. Distribute appropriate training

materials and guidelines. Distribution of protocol

amendments and IND safety letters to sites. Oversee

ordering, shipping, tracking, and return of drug, ancillary,

and other clinical supplies. Performed other

project-related duties as required, demonstrated knowledge

of the drug development process, clinical practices; company

SOPs, and Federal guidelines governing clinical trials.

Clinical Medical Admin Assistant September 2005 -

March 2006

Impetus Healthcare Division, North Brunswick, NJ

Obtained hands and practical experience in patient

preparation, interviewing, documenting medical history and

medical transcription, billing and coding. Reviewed medical

records and provided chart organization. Obtained patient

vital signs handling related medical equipment which

provided exposure to Phlebotomy techniques (Vacutainer

systems, syringe methods, capillary punctures & routine Veni

punctures), handling of antiseptics, Vacutainer tubes,

needles, and adaptor. Informed on safety procedures in a

healthcare setting. Performed 12 Lead EKG and administer

EKG records.

Clinical Trial Assistant

July 2000 - February 2005

Sanofi-Aventis, Bridgewater, NJ

Held two positions at Sanofi-Aventis over a period of 4

years

Accurate updates and maintenance of clinical systems

including EZ-Clin, PROFILE and IMPACT that track site

compliance and performance within project timelines. Assist

the clinical team in the preparation, handling,

distribution, filing, and archiving of clinical

documentation and reports according to the scope of work and

standard operating procedures. Coordinate restocking of

clinical supplies and collated SAE information, Assist

with periodic review of study files for accuracy and

completeness. Assist with the tracking, reconciliation and

management of Case Report Forms (CRFs), study enrollment

information, queries and clinical data flow. Act as a

central contact for the clinical team for designated project

communications, correspondence and associated documentation.

Other administrative duties as required to include budget

management, invoice payments, calendar maintenance, travel

arrangements, expense reports, training session coordination

and training material.

Senior Administrative Coordinator,

Provided administrative support for The Director of North

America Clinical Operations and members of the Senior

Leadership Team. Generate PowerPoint presentation, documents

and spreadsheets in Microsoft Office. Set priorities and

follows up to ensure coordination and completion of assigned

work. Budget control includes preparation of expense

reports and vendor payments. Extensive calendar management,

meeting and events coordination included arrangement and

site selection for meetings, conferences, and programs (on-

and off-site), including hotel, catering, room setup,

audiovisual services, staff support, security, video

teleconference, and local transportation. Special projects

as assigned.

Union County College

Education/Certificatio Relevant courses: General Business, Communications

ns The Cittone Institute:

Certified in Office Automation

Inpetus health Division

Clinical Medial Assisting Certification

Bakers College

BA Business Administration, in progress (anticipated

completion date - 2017)

Computer Skills MS Word, PowerPoint, Excel, LRN, MS Internet Explorer,

QuickBooks, Palm Pilot, MS Exchange, MS Outlook, Pay Mail,

Netscape, Windows, Ami Pro, Freelance for Windows, IMPACT,

DOS Freelance, WordPerfect, Samna, Harvard Graphics, AT&T

Access plus, Lotus 1-2-3, Vouchriter, Telephone Concession

Writer, Meter, Time Traxs, Tempo, Beacon, Crystal Reports,

Documentum, ClinDocs, Novo Docs, CTSRS, GRIPS, Spectrum,

eTMF, Grants Management System (GMS), eRoom, CTMS.

IMPACT/Business Objects, LiveLink, SharePoint

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4301 Birchwood Ct.

North Brunswick, NJ 08902

Phone: 848-***-****

E-Mail:

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

Clinical Research and Drug Development Professional

Ella Morrison

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