Management Clinical

Sofia Caamano

** ****** ****** . *******, ** **002

HOME 201-***-**** . E-mail ********@*****.***

Summary

Experienced Clinical Scientist with expertise in authoring the following

clinical and regulatory documents: Clinical Protocols, Clinical Study Reports,

Protocol Amendments, Administrative Letters, Investigator Brochure Safety

Updates, Preparation and Review of Safety Sections for IND Updates, Preparation

of Clinical Sections for FDA Briefing Books, Integrated Safety Summaries,

EudraCT Forms, Site Training Materials, and Newsletters. Experienced in the

following therapeutic areas: infectious disease, allergy, respiratory,

gastroenterology, cardiovascular, and immunology.

Responsibilities are summarised below:

Prepare study protocols, Ensure regulatory Site selection and

amendments, administrative compliance Initiation visits

letters, IB addendums,

Abbreviated CSRs, Full CSRs,

site training materials,

and contribute to Integrated

Safety Summaries, safety

sections of INDs, briefing

books, and EudraCT forms

Review site budgets Experienced in

Documentum

Manage external vendors Enrollment Tracking

Management of IP/Study Query resolution

Supplies

Coordinate with data Serve as primary contact

management, statistics, for sites

and regional monitors to

create CRFs, data review

plans, and site

monitoring plans

Prepare and review informed Management of SAEs

consents

Update and maintain study Monitor and co-monitor

files studies

Education

Date Place of Education Degree/Qualifications

2005 Columbia University, NY, M.A. in Biotechnology

NY

2001 Rutgers University, B.A. in Biology

Newark, NJ

Employment History

Employer/From - To Roles & Responsibilities

Forest Research Sr. Clinical Scientist (Consultant)

Institute Responsible for managing start-up activities for a

Jersey City, NJ Global Phase III COPD study.

November 2009 - Present

Effectively manage internal and external vendors to

ensure that study deliverables are met.

Schering-Plough Sr. Clinical Research Associate (Consultant)

Kenilworth, NJ Successfully manage and execute multiple assigned

January 2007 - November protocols as a Lead Protocol CRA and Study Team Leader.

2009

Operationally lead and implement clinical studies

according to agreed timelines for the Clinical

Pharmacology group.

Responsible for developing clinical protocols, protocol

concept sheets, amendments, and presenting and

defending protocol concept sheets and study protocols

at Protocol Review Committee (PRC).

Responsible for reviewing and providing writing support

for clinical development plans, safety updates to IND,

EudraCT forms, briefing books, synoptic study reports,

abbreviated study reports, and full CSRs.

Assist with eCRF development by reviewing and providing

feedback to Clinical Data Management (CDM).

Novartis Pharmaceuticals Clinical Research Scientist

Responsible for managing start-up activities for Global

Global Neuroscience Phase III studies in Major Depressive Disorder

East Hanover, NJ including protocol development. Responsible for

September 2006 - January developing site materials such as laboratory manuals,

2007 newsletters and content for central study websites and

recruitment websites.

Bristol-Myers Squibb Associate Clinical Scientist

Clinical Discovery- Responsible for managing multi-center infectious

Infectious Disease disease patient studies as well as first-in-human

Lawrenceville, NJ healthy volunteer studies and Clinical Pharmacology

August 2005 - September support studies including Phase IV life cycle

2006 management studies.

Organized and authored clinical study protocols,

protocol amendments, abbreviated study reports, final

study reports, and contributed to Investigator brochure

addendums, and integrated and expedited safety

summaries.

Effectively managed all operational aspects of studies

from protocol concept sheet to completion of study

report.

Experienced in monitoring Clinical Pharmacology

studies, as well as Phase IV life cycle management

studies from pre-study visits to closeout visits.

Columbia University Senior Research Staff Assistant

New York, NY Explored the mechanical properties of proteins using

July 2001 -February 2005 atomic force microscopy.

Performed independent experimental research related to

clinically relevant neuroscience targets such as

(-amyloid.

Responsible for performing molecular biology and

polyprotein engineering for the laboratory.

Publications

Sarkar A, Caamano S, Fernandez JM. The mechanical fingerprint of a parallel

polyprotein dimer. Biophys J. 2007 Feb 15;92(4):L36-8.

Sarkar A*, Caamano S*, Fernandez JM. The elasticity of individual titin PEVK

exons measured by single molecule atomic force microscopy. J Biol Chem. 2005

Feb 25;280(8):6261-4.

*co-first author

Professional Memberships

Association of Clinical Research Professionals (ACRP)

American Medical Writers Association (AMWA)

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