Manager Clinical Research Contracts & Grants

Phone: 510-***-****

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

Marisa A. Capponi, CCRA

Fourteen years of clinical research experience, most currently as Sr. CRA /

Summary Manager Clinical Contracts and Grants team responsible for full cycle global site

contracts and budgets supporting large scale phase 2-3 studies for Clinical

Operations. International & pediatric experience. Strengths include outstanding

negotiator, detail-oriented, organized, ability to prioritize, dependable, flexible, and

committed team player.

BioMarin Pharmaceutical Inc.

Clinical

San Rafael, California

Experience

September 2005 – March 2015

Senior CRA/Manager Clinical Contracts & Grants – Clinical Operations,

January 2011 - March 2015

Manager of site contracts and budgets and negotiator for site budgets across

multiple programs, including management of CROs handling the site

contract/budget negotiations on our behalf for over three years. Building and

amending site budget templates and site specific budgets based on fair market value

cost benchmarks. Interacting/liaising with all internal departments and establishing

strong working relationships, especially with legal, sites, CROs and the clinical

operations study teams. Responsible for the timely execution of site contracts in

order to meet the study goals. Develop contract/budget processes and guidelines.

Mentors, trains, and supervises staff. Serve as a direct report. Also, continue as

relationship manager and operational owner for several vendors (eg, Greenphire,

Grants Manager).

Clinical Research Associate I, II, Senior CRA - Clinical Operations,

September 2005 - February 2011

Performing clinical research duties that included participation in the following

areas: protocol/ICF development, study planning/start-up, site/vendor selection,

implementation, conduct/oversight/advise, independent clinical study/site

monitoring and management, negotiate study budgets/contracts, Investigator

Meetings, lead CRO management and reporting, train CRAs and Assistants, work

with all internal departments, review AEs, enrollment and data quality. Perform

under minimal supervision. Support and manage the implementation and day-to-

day operational activities. Implement new processes as company continues to

expand.

Worked on BioMarin’s genetic, cardiovascular, and oncology studies domestically

and internationally primarily in-house (Phase 1 – IV). Was the lead CRA on a

sickle cell study and on a pediatric, Phase 1/2, rare genetic disease study for

Morquio syndrome held in the United Kingdom.

Updated: 28 April 2015

Genelabs Technologies, Inc.

Redwood City, California

April 3, 2000 – September 2, 2005

Clinical Research Assistant, Associate I-II – Clinical Operations

As a CRA, main responsibilities would be helping to plan and initiate a study, and

assessing the conduct of studies. Working with the clinical research coordinator to

check all data and documentation from the study. Also responsible for Regulatory

Documents, Tracking/Logs, and Initiating/Tracking Investigator sites, clinical study

monitoring and management, study/department budgets and CRO management.

Worked on Genelabs’s lupus studies domestically and in Mexico.

Bachelor of Science in Health Science – May 1999

Education California State University, Hayward

Research Technician -Aclara BioSciences, Inc.

Additional

Mountain View, California

Professional

November 8, 1999 - March 31, 2000

Activities

Office Manager/ Dental Assistant – Bill T. Cavalli, DDS

Berkeley, California

January 1991 – September 24, 1999

Grants Manager (MediData) Certified User

Organizations,

Certified Clinical Research Associate (CCRA) – since October 2007

Skills and

Awards Association of Clinical Research Professionals (ACRP) Member

Strong computer literacy: Word, Excel, Access, Outlook, PowerPoint, MS

Project, Grants Manager, IVRS, MediData (EDC), Trialworks (CTMS),

ARIBA

Team Player with great communication skills

Knowledge and understanding of FDA and ICH Guidelines, GCP's and

medical terminology

Outstanding Performance Awards (Genelabs –‘02, BioMarin – ‘07, BioMarin-–

‘08)

Updated: 28 April 2015

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