Project Manager Clinical Research

Jacqueline Robinson

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

Charles Town, WV 25414

E-mail: ********************@*****.***

Home #: 304-***-**** / Cell #: 443-***-****

Objective

A position in the Clinical Trials arena as a Clinical Research Associate, Project Coordinator, Associate Project Manager, Document Control or Trial Master File Specialist.

Professional Experience

ExecuPharm, Inc. - King of Prussia, PA

CCTR Remediation Lead, Contractor for Pfizer Clinical Studies (Oct 2011 – May 2012)

• Review study records in Client registry and perform relational QC as required between/amongst documents as needed.

• Provide reports to identify all required data points per study (list of required data points provided by Pfizer).

• Identify potentially incorrect and missing data points, and review total registry record with study team members.

• Instruct study team members on how and where to find required data point information, and collect information and location of applicable source documentation for data points from study team.

• Provide Data Entry Specialist with required information to make necessary entries/corrections to each study in the Client registry.

• Responsible for meeting client productivity metrics

Technical Resources International, Inc. - Bethesda, MD

Inside Clinical Research Associate II (July 2010 - September 2011)

• Performs a Quality Review Assessment to insure accuracy, completeness and compliance with requirements and guidelines referenced in ICH GCP Guidelines, DMID Regulatory File Document Guidelines, 45 CFR 46, 21 CFR 50 and 21 CFR 312.

• Processes submitted regulatory documents entering required data for the purpose of tracking and reporting critical data elements

• Communicates deficiencies within Essential Documents with Clinical Research Sites and provide assistance to determine adequate resolution

• Provides training to new personnel on the processing of regulatory documents in accordance with GCP (Good Clinical Practices) for clinical studies located at U.S. and Foreign study sites.

• Prepares and distributes regulatory documents to Clinical Research Sites to assist with maintaining compliance with applicable regulations.

• Creates new and revises current operating procedures and work instructions for government contracts.

• Provides weekly reports to accommodate the requirements of external clients as well as internal management needs.

• Established a daily tracking/accountability spreadsheet which assesses the work objectives for the team to process essential regulatory documents within the timelines as written in the department’s Project Work Instructions (PWIs).

• Provides technical writing skills in the development of the electronic database instructions for the uploading and maintenance of essential regulatory documents for clinical trials in accordance with ICH GCP Guidelines, DMID Regulatory File Document Guidelines, 45 CFR 46, 21 CFR 50 and 21 CFR 312.

• Provides assistance to Clinical Research Sites, Operations Support Centers and other authorities via a telephone support help desk.

Global Research Services, LLC - Rockville, MD

Project Coordinator (January 2008 – June 2010)

• Primarily, supports the Project Manager (PM), Lead Clinical Research Associate

(LCRA) and other members of the project team.

• Provides all in-house support needed by CRAs (site managers).

• Sets up, tracks, and facilitates adherence to timelines using MS Project (and

other relevant tools).

• Provides overview of study timelines, potential bottlenecks, resource needs etc.

to ensure the smooth operation of the project.

• Assists with the collection of Budget Tracker input monthly from all relevant

departments and assists PM with the preparation of the input for review by PM prior to monthly project review meeting.

• Sets up and ensures entry of project related material into internal proprietary

project tracking systems, primarily CTMS.

• Sets up tracking tools/procedures (usually spreadsheets) based on the unique

requirements of the project to include Monitoring Report Tracking, Patient Screening & Enrollment, Training of Study Sites, and Device/Drug Accountability.

• Ensures that sites receive all the documents (including regulatory documents),

tools and supplies needed to meet the objectives of the project. Specifically

regulatory Binders, Operations Manuals, Investigator Brochures, Instructions for

use and CRFs (Case Report Forms).

• Tracks all Regulatory Documents to ensure completeness, accuracy, availability and currency.

• Created Flash-Cards for three device studies on Inclusion and Exclusion Criteria

as ready-reference for study site Study and Research Coordinators.

• Created marketing posters for two device studies per Sponsor requirements for

patient awareness at study site clinics.

• Coordinates all project-related internal and external reports, communications,

correspondence, meetings, and minutes.

• Works directly with third party vendors to complete all contracted tasks to include

• Device and Drug Accountability.

• Increases efficiencies and recommends process improvements for project

support processes.

• Assists management staff in other project-related and non-project related

activities, as assigned.

Johns Hopkins University School of Medicine, Baltimore, Maryland

Project Coordinator / Administrative Coordinator (October 2005 to December 2007)

• Performance of administrative services for two Research and one Immunology

Core Laboratories, one Professor of Oncology, Medicine, and Urology, the

Director of a Human CORE Facility, two Assistant Professors of Oncology and

one Clinical Research Nurse.

• Manages patient billing for clinical trials, meeting and working closely with

research nurses to ensure eligible research study costs, insurance requests, and

patient co-pays are appropriately charged.

• Coordination of the transfer of research mice between central facilities and

research laboratories.

• Locates and compiles information and formats reports, graphs, tables, records

and other sources of information.

• Assembles and categorizes facts and figures for written computation and

calculations.

• Planning and coordinating special events including The Interurban Clinical Club

two day conference and Black-tie dinner for Board of Directors and 50 plus active

and emeritus members of the Mid-Atlantic region.

• The creation and maintenance of Excel spreadsheets for the Bone Marrow

Transplant Grant Award, Core D and Project 2, $2.5 million direct costs.

• Responsible for the sorting, cataloging, binding and archiving of clinical trial data

as directed by the Immunology Clinical Research Nurse for ongoing and closed clinical trials.

• Creation of a relational database for the reporting of Severe Adverse Effects for

patients enrolled in the clinical trial study of Velcade in report format submitted to

the Federal Drug Administration (FDA).

• Coordinates and implements office services such as payroll, purchasing, records

control, projects and budget accounting operations.

• Prepares and/or participates in the preparation of the budget for the Division of

Immunology and Hematopoiesis.

• Develops and recommends the budget for approval.

• Analyzes historical budget patterns and forecasts short-term and long-term

needs.

• Controls expenses and increases productivity to improve budgetary performance

by monitoring spending and reconciliation of budgets monthly.

• Analyzes unit operating practices such as record keeping systems, forms control,

office layout, and personnel requirements, creating new systems or revising

established procedures.

• Interprets and communicates operating policies.

• Coordinates collection and preparation of financial and operations reports.

• Monitoring and maintenance of animal, human products, DNA, and radiation

protocols.

• Assists in the hiring of new individuals including Lab Technicians, Postdoctoral

Fellows, Research Associates, Rotating Students, and Summer Students,

including the coordination of interviews, the creation of job descriptions,

advertisements, and paperwork involved in the recruitment process.

• On a regular and continuous basis, exercises administrative judgment and

assumes responsibility for decisions, consequences, and results having an

impact on people, costs, and/or quality of service within the functional area.

• Oversees or coordinates the work of others by monitoring productivity and output

of lab members.

• Service Center billing for the Human Immune Core Laboratory, which includes

the invoicing and transferring of funds from internal and external budgets of

principal investigators.

• Design and distribution of the "T Cell Chronicle Newsletter" for the Human

Immunology Core Laboratory.

• Web Site upkeep for http://humanimmunology.onc.jhmi.edu.

• Liaison with vendor's world-wide to obtain laboratory supplies for cancer

research in myeloma and lymphoma clinical trials and therapeutics.

• Design and creation of Scientific Posters for the Oncology Core and

Biotechnology Scientific Fairs, along with all of the marketing materials which

includes: brochures, business and rolodex cards, service request forms, hand

outs on the Core Lab's Web Site, Newsletter and Marketing Folder.

• Operates personal computer to access e-mail, electronic calendars, and other

various software applications, such as spreadsheets, relational databases,

statistical packages, and graphics packages to assemble, manipulate and/or

format data and/or reports.

Johns Hopkins University School of Medicine, Baltimore, Maryland

Administrative Assistant (October 2001 to October 2005)

• Performance of administrative services for three research laboratories, one

Professor, one Assistant Professor, and one Medical Physician.

• Designed and created molecular scientific models for the incorporation to journal

articles published in National Scientific Journals.

• Coordinated office services as purchasing, payroll distribution, visa, records

control and other administrative activities.

• Research and compilation of information for formation into reports, graphs,

tables, records and other sources of information for statistical analysis.

• Reconciliation and maintenance of 32 sponsored divisional research grants.

• Requisitioning of laboratory, office and computer supplies.

• Responsible for procedural requirements in the preparation and submission of

National Institutes of Health (NIH), American Cancer Society (ACS), Department

of Defense (DOD), Cigarette Restitution Fund (CRF), National Cancer Institute

(NCI), Flight Attendant Medical Research Institute (FAMRI) and Prostate Cancer

Foundation (PCF) grants.

• Preparation of monthly Principal Investigator Financial Reporting, which details

total expenditures for faculty and staff salaries, fringe benefits, animal usage,

laboratory supplies, computer and equipment purchases, office supplies, and

travel both foreign and domestic.

• Responsible for the preparation and submission of H-1B1, J1, and F1 Visa

packages for Post Doctoral Fellows, Graduate Students and their families from

aboard.

• Procurement of major equipment purchases totaling more than $500,000 for new

Medicinal Chemistry Core Laboratory.

• Budgetary analyst for Medicinal Chemistry Core Laboratory's financial reporting

and inventory.

• Assisted with special events planning.

UNITED STATES NAVY

Aviation Maintenance Administration (August 1980 - November 1995)

Education

• MBA with Concentration in Regulatory Compliance, Hood College, Frederick,

MD, Aug 2009 to Present

• Project Management Certification Courses (on-line), July 2012 to Present

• MBA courses, Masters of Business Administration, Johns Hopkins University,

The Carey Business School, Baltimore, MD, Aug 2007 to August 2009

• B.S. in Business and Management, Johns Hopkins University, Baltimore, MD,

Dec 2004

• Courses in Business Management, Catonsville Community College, Catonsville,

MD, Sept 1999 to Aug 2002

Training/Certification

• Johns Hopkins University, Center for Training and Education, Hopkins

Information Technology Services, Baltimore, MD

• Coeus Premium Proposal Development, Dec 2007

• General Ledger Non-Payroll Cost Transfer Initiator, Workshop II, April 2007

• General Ledger Non-Payroll Cost Transfer Initiator, Nov 2006

• Non-Payroll Cost Transfer, Nov 2006

• SAP Business Workplace Navigation for Johns Hopkins University, Nov 2006

• SAP Navigation for Johns Hopkins University, Nov 2006

• AP Online Payment Requester for Johns Hopkins University, Oct 2006

• Controlling Overview for Johns Hopkins University, Oct 2006

• Expense Reimbursement Management Overview for Johns Hopkins University,

Oct 2006

• Finance Overview for Johns Hopkins University, Oct 2006

• Shopping Cart Q&A Session, Sep 2006

• Sponsored Projects Overview for Johns Hopkins University, Sep 2006

• SRM Requisitioner for Johns Hopkins University, Sep 2006

• Travel & Business Expense Request Assistant for Johns Hopkins University, Sep

2006

• Coeus CUFS (NIH Electronic Grant Submission) CUFS, Sep 2006

• Improving Our Work Processes, June 2004

• Managing Workplace Conflict, May 2004

• Microsoft PowerPoint Intermediate, March 2003

• Adobe Acrobat 5.0 Introduction, Feb 2003

• Endnote 6, Feb 2003

• OMB Circulars - Administrative Requirements & Audits, June 2002

• OMB Circulars - Procurement Under Grants, June 2002

• OMB Circulars - Cost Principles, June 2002

• OMB Circulars - Intro to Grants & Cooperative Agreements, June 2002

• CUFS Account Inquiry, May 2002

• Accounts Payable System, May 2002

• Coded Invoices & Check Requisitions, April 2002

• Business Travel & Independent Contractors, April 2002

• Electronic Journal Vouchers, March 2002

• Procurement Process - purchasing Policy, March 2002

• Electronic Materials & Services Form (EMNS), March 2002

• Post Award Administration - Research Accounting, March 2002

• Cash Accounting, Feb 2002

The William H. Welch Medical Library, Baltimore, MD

• Intro to Grant Writing, Sept 2002

• Library 101, March 2002

• Adobe Acrobat 5.0; Working with .PDF's, March 2002

• Pub Med, Feb 2002

• Catonsville Community College Continuing Education, Catonsville, MD

HTML & Web Page Design Immediate, Aug 1999

HTML & Web Page Design July 1999

• Neighborhood Reinvestment Training Institute, Chicago, IL

Capital Financing Strategies, July 1999

Identifying Financial Alternatives, July 1999

• Neighborhood Reinvestment Training Institute, Philadelphia, PA

Marketing Your Programs, June 1999

Balance Sheet Clinic, June 1999

• Principles and Practices of Non-Profit Management, March 1999

• AAI Corporation, Hunt Valley, MD

Genesee Valley Teambuilding Training, May 1997

• Certificate - Immediate Windows, July 1996

• Certificate - Exploring the Internet w/Novix, July 1996

Computer Experience

• Microsoft Windows Office Suite 2010

• Microsoft Project

• Microsoft Access

• Adobe, Adobe Publisher

• HTML

• QuickBooks

• Visio

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