Toni Brown has over 15 years of experience in clinical research, specializing in coordinating, managing, and supporting all phases of clinical trials. She has expertise in areas such as protocol reviews, site management, regulatory documentation, and TMF management. She is proficient in MS Office, clinical trial databases, and has strong communication and organizational skills.

1. TONI BROWN
87 Briarwood Ct. Howell, NJ 08771 732-890-4188
www.toniann0408@gmail.com
SUMMARY
Detail oriented Clinical Research Professional with expertise in coordinating, managing, and
supporting all phases of clinical studies and trial master files for both pharmaceutical
(oncology, immunology, infectious disease, pediatric neurology, CNS, Psychiatry, and
medical device (dialysis) trials, protocol reviews, study start up, site management and support.
Specializes in program administration, information management, logistics coordination, project
management, business communications, and expense tracking. Strong organizational,
planning and collaboration skills. Demonstrated success communicating and liaising across all
department levels and outside vendors. Extensive prior experience working in a healthcare/hospital
setting, in multiple disciplines, lending valuable knowledge of medical terminology, disease states,
process, and treatments, diagnostic tools and medical procedure, as well as ease of communication
with medical professionals of all levels and specialties. Known for discretely handling confidential
information, and managing multiple priorities with ease and efficient and ongoing communication.
Works effectively both independently and within teams completing projects on deadline while
ensuring quality and customer satisfaction using strong expertise in:
Regulatory Documentation
Recruitment Support
Site Training
GCP Guidelines
Protocol Review
Education Materials Development and Review
Consent Review
Contract/Budget Development and Negotiation
Meeting and Event Coordination and Participation
Expense Reporting and Reconciliation
TMF Management
COMPUTER AND TECHNICAL SKILLS
MS Word, MS Excel, MS Access,MS PowerPoint,MS Project,FrontPage,Outlook, Adobe Acrobat,
MS Live Meeting, Lync, ACCELIM, GEPIC, IMPACT, Resource Scheduler, CTMS

2. ToniBrown www.toniann0408@gmail.com (2)
PROFESSIONAL EXPERIENCE
InVentiv Health Clinical, Princeton, NJ 4/2015-Present
TMF Associate/Clinical Research Associate
 Represent inVentiv Health to the customer, ensuring satisfaction levels are maintained
and program deliverables are communicated effectively
 Oversee interdisciplinary clinical research programs
 Responsible for TMF Management Plan and quality and completeness of TMF for
assigned projects
 Accountable for all project deliverables for each project assigned
 Coordinate activities and deliverables of all study conduct partners and proactively
identify and manage issues
 Ensure studies are conducted in compliance with GCP, relevant SOP's and regulatory
requirements
 Accountable for maintenance of study information on a variety of databases and
systems
 Responsible for study management components of inspection readiness for all aspects
of the study conduct
 Oversight for development and implementation of project plans
 Plan, coordinate and present at internal and external meetings
 Direct the activities of assigned project support staff
 Prepare project management reports for clients and management
 Implement resource strategies to achieve project goals
 Developing contingency planning and risk mitigation strategies to ensure successful
delivery of study goals
 May train and support new project staff
 Responsible for performing activities that are in compliance with applicable
Corporate and Divisional Policies, Standard Operating Procedures and Operating
Guidelines and performing other duties as assigned by management
 Set priorities and schedule activities of departmental resources, implement company
objectives, and create alternative solutions to address business and operational
challenge

3. Advanced Clinical-Otsuka Pharmaceutical Development & Commercialization, Inc.,
Princeton, NJ 7/2013-4/2014
Clinical Project Administrator (Contract)
 Assist in maintenance, quality control, distribution, and archiving of clinical
documents and reports improving quality and expediting processes.
 Support development of program specific standards (e.g., agendas, minutes, filing
structure, team materials) ensuring complete documentation and expedite processes.
 Assist with the management and maintenance of team contact lists, calendars, and
organizational charts.
 Participate in meeting logistics, events and training to improve quality and expedite the
process, including (but not limited to):
-scheduling meetings
-set up of AV, conference equipment and preparation of relevant materials
-scribe and prepare minutes from critical meetings.
-participate in clinical team meeting discussions.
 Responsible for contracting and invoicing of key advisors/vendors/external service
providers expediting contracting processing, and ensuring compliance of all contracts, in
assigned area(s)by: -ensuring timely receipt of confidentiality agreements
 -ensuring complete documentation is on file for advisors/vendors
 -assisting with the terms of service, budget creation, template structure
 -providing input to appropriate plans for vendor contracts (sows)or overall agreements
-tracking and renewing documentation for contracts and invoices
 -ensuring coding, payment and follow through of invoices where assigned
 Serve as a resource to the clinical team and external service providers in areas of
expertise such as: creation and organization of slide presentations, internal databases and
electronic systems applications (EDMS, Legal databases), and internal process
management (contracting, invoicing, database search).
 Provide liaison support between global affiliates, external vendors and the clinical
research teams.
EDUCATIONAL RESOURCE SYSTEMS, Red Bank, NJ 12/2012 – 12/2013
Freelance Quality Assurance Assistant (On Call)
 Review and revision of medical education information and programs.
 Develop and institute changes, updates and corrections as necessary.
 Communicated and collaborated with support departments, such as programming
and art production to ensure quality of education and training materials.
 Conform with deadlines to provide complete, accurate, and comprehensive education
and training materials to client.

4. IPSEN, Bridgewater, New Jersey 1/2012-5/2012
Clinical Project Assistant
 Ensured clinical operations functions are supported in order to assist the delivery of
clinical operations objectives.
 Ensured the study master file is organized, maintained, and complete, both as paper
documents and electronic files.
 Responsible for all aspects of the establishment, tracking, maintenance and archiving
of the trial master file, including the collection of study documents from monitors and
CRO .
 Identified and prepared documents for the study sites and for regulatory
submissions.
 Participated in the process of clinical drug order and ancillary supply coordination,
vendors coordination.
 Initiated, negotiated, and followed up with contract and budget development with
study sites and legal staff representing both site and Ipsen.
 Assisted, prepared, and attended study coordinator and investigator meetings with
the clinical operations team.
 Assisted the project manager in co-monitoring visits, as required, to review the
study files at the study sites, and to facilitate data retrieval.
 Ensured clinical operations functions are supported in order to assist the delivery of
clinical operations objectives through collaboration with all departments, including
finance, legal, and it, as well as global operations.
 Assisted and is responsible for the clinical operations staff, sites and vendors
through financial follow up of the study.
CLINFORCE-MERCK,Springfield, New Jersey 2011-12/2012
RegulatoryDocumentAssociate (Contract)
 Performed system administration activities required to activate/initiate/closeout
study sites or studies in phase ii to v clinical trials and manage the input of data into
specific applications.
 Performed manual data entry in: CTMS, TMF, CRF imaging and various
departmental databases.
 Monitored/tracked appropriate documentation to meet contracted and agreed upon
timelines.
 Maintained weekly document processing metrics/errors/returns/delays for
department.
 Ensured consistent receipt, analysis, classification, registration and
disposition/filing/retrieval of hardcopy and electronic clinical trial essential documents
and other clinical trial related documents to allow for their consistent tracking,
inspection and security.

5. Toni Brown www.toniann0408@gmail.com (5)
K-FORCE-NOVO NORDISK,Princeton, New Jersey
7/2008-1/2009
Project Associate/In House CRA (Contract)
Distributed study related materials to sites - protocol, IB, study manuals and supplies etc.
Maintained status reports and document quality control.
Reviewed and processed regulatory documentation ensured the execution of clinical trials in a
timely, efficient manner, working within established timelines and budgets.
Collected and maintained a file of regulatory documents, study documentation and
communication for each study.
Consistently tracked and updated study metrics in internal systems and reported such to Project
Manager.
 Performed consent review for assigned protocols.
 Participated in site training and support for assigned protocols.
RADPHARM,Princeton,New Jersey 2/2004-7/2008
Senior Project Coordinator,2007- 2008
Performed all duties of a project coordinator.
Assisted in research, collection and presentation of study metrics alongside project leadership and
support departments in order to provide findings to clinical research organizations (CRO)and sponsors as
needed.
Collected, maintained, and updated study documents and correspondence related to protocol
requirements and adherence.
Reviewed, prepared, and coordinated distribution of supplies and related materials to study sites.
Planned, coordinated, and led in the site initiation process for study monitors, study coordinators,
principal investigators, and all related site staff.
Prepared and reviewed weekly/monthly reports for delivery to CRO and sponsor.
Participated in the development, review, and evaluation of standard operating procedures (SOPS).
Recorded raw data on source documents, clinical reporting forms (CRFs), etc.,along with
performing quality assurance of this recorded data.
Mentored new project coordinators as well as participating in the development of the mentoring
and training procedure.
Assisted project management in 3 month and yearly employee evaluations of new staff members.
Prepared presentations as needed for instructional purposes concerning Radpharm and protocol
procedure, and conducted appropriate presentations to Radpharm staff.
Anticipated and adhered to all study timelines.
Prepared slide presentations of instructional materials for protocol site staff.
Project Coordinator, 2004-2007
Executed the technical functions required by the study protocol, and collaborated with the study
team to facilitate study process in accordance with company standard operating procedures.
Prepared images for quality assurance (QA), and assisted the radiologist in film reads as directed
by study protocol.
Prepared, reviewed, and provided information for presentation to CRO and sponsors as needed in
relation to audits and protocol reviews in relation to Radpharm roles.

6. Participated in sponsor visits, as with both external and internal audits as a team member along
with team leaders and managers by preparing information and data required.
Composed and reviewed additional requirements and responded to all requests during protocol
related visits and audits.
Performed all corrective actions deemed necessary for internal and sponsor audits to ensure
protocol compliance.
Initiated and instructed research site staff members of Radpharm policy and procedure in regard to
protocol requirements.
Interacted with study coordinator(s) and, all other appropriate site staff members to ensure
protocol requirement adherence,proactively, through monitoring, review, and implementing instruction
and training as needed.
Interacted with sponsor and CRO staff as to ensure all protocol adherences by way of
communication and reporting of site participation and progress.
Entered and tracked data in database, and maintained security of radiological
images, confidentiality of information and study protocols, and privacy of subject information
according to federaland international laws and guidelines.
Collaborated with management and co-workers to resolve technical, procedural, and study related
concerns and issues.
K- FORCE SCHERING-PLOUGH CORPORATION,Springfield, New Jersey
4/2003-2/2004
Clinical DocumentationSpecialist(contract)
Responsible for archival and retrieval of clinical data from clinical trials in phase ii and iii of
research.
Reviewed and maintained data of general study documents (protocols, investigator brochures,
1572’s, etc.) in oracle database.
Generated and reviewed reports for reconciliation with clinical operations.
Responded to requests for information from various clients such as regulatory affairs, clinical data
management, and clinical operations.
Maintained continuing education in regard to ICH/GCP guidelines, FDA regulations, SOPS, and
clinical trial process.
Reviewed CRFs and all study related documents for consistency, completeness, and to identify
errors.
Education
Fairleigh Dickinson University , Madison, New Jersey- Certificate in Paralegal Studies, March 2003
Rutgers College, New Brunswick, New Jersey- Bachelor In Arts With Honors, Political
Science/Communications, May 2002
Ocean County College, Toms River, New Jersey- Associate In Arts, May 1999
Currently completing PMP reviewcourse in preparation for certification testing.
Therapeutic Experience
Oncology- Lung, Breast, Colorectal, and Prostate Cancer Phases I – III, Immunology/Infectious
Disease- Hepatitis C Phases II – III, Medical Device – Dialysis Phases I & II, Pediatric Neurology
Phase III, CNS Phases I-III

7. Toni Brown www.toniann0408@gmail.com (7)
Medical and Patient Care Experience
Oncology, cardiology and open heart, surgery, trauma, pediatrics, mental health, pharmacy,
laboratory and radiology diagnostics, emergency medicine, and geriatrics.