Manager Management

SUMMARY OF EXPERIENCE:

Dedicated Professional Bilingual Accountant and Clinical Study Associate

with more than 11 years of experience in Phase I/II/III trials.

Comprehensive knowledge of clinical and accounting practices, clinical

trial monitoring and design controls. Familiar with the practices and

methods of clinical trial methodology and research. Combine

resourcefulness and problem solving skills with clinical knowledge to

consistently deliver improved research and production results. Team player

dedicated to quality, strong communication, and good interpersonal,

organizational skills.

PROFESSIONAL EXPERIENCE:

Tax Professional & Accountant - Inspiration Tax Services, Cary, NC 27511

September 2013 - Present

. Compute taxes owed by following tax code.

. Prepare or assist in preparing simple to complex tax returns for

individuals or small businesses.

. Help taxpayers by using their federal, state and local codes and see

to it that clients receive the maximum benefit permitted under the law

of government.

. Uncover potential deductions and credits.

. Advise against potential tax liabilities.

. Ensure clients do not pay unnecessary taxes.

. Review financial records such as income statements and documentation

of expenditures.

. Interview clients to get a thorough picture of financial situation.

. Verify totals on past forms for accuracy.

. Consult tax law handbooks for especially difficult tax returns.

. Resolve customer complaints.

. Prepare tax returns using electronic filing software.

. Ensure a copy of the completed return is provided to the customer.

. Determine accounting systems, available to support the liquidation and

payment.

. Ensures that appropriate authorizations, certifications, other

documents are on file and that payments are in accordance with the

provisions, terms, and conditions of the applicable authorizing

documents such as contracts, purchase-orders, receiving and

inspection reports, grant and/or loan agreements

Clinical Monitoring Associate II, Parexel, Durham, NC, United States

January 2012 - September 2013

. Collaborate with CRA on site issues/actions. Create and distribute study

document (e.g. eSignature Agreement, Amendments, etc.)

. Initial and ongoing drug / supply management. Update all relevant

tracking system on an ongoing basis

. Perform regular reviews of data according to data review/monitoring

guidelines (CTMS, EDC,

IVRS, ISIS)

. Conduct remote visits (initiation, monitoring, termination. Primary in-

house site support)

. Collect updated/amended regulatory documents in collaboration with CRA

and CTS as needed

. Build relationships with investigators and site staff remotely

. Maintain a working knowledge and ensure compliance with applicable ICH-

GCP Guidelines,

Local regulatory requirements and PAREXEL SOP and stud specific procedure

(e.g. Monitoring Plan)

. Complete routine administrative tasks in a timely manner (e.g.

timesheets, metrics) Establish and maintain necessary internal controls

to ensure that payments are not made in excess of the authorized amounts

as well as to prevent improper or duplicate payments.

. Performs in depth research on issues/queries from vendors, sites, related

to payments, liquidations, and obligations.

. Communicates with contractors, sites, vendors to request additional

information regarding invoices, applicable to contracts and

other agreements.

. Responsible for the completeness and quality of the in-house site

specific files (in cooperation

With ROA/RMA).

Clinical Study Associate, GSK - Subcontracted for Trio Clinical Research,

RTP, NC United States

November 2006 - May 2011

. Coordinated Clinical activities on multi centre trials team including

maintenance of documentation, clinical tracking and information retrieval

. Assisted with general administrative functions as required; conducted co-

monitoring assignments reviewing Trip Reports (Site Selection, Site

Initiation, Site Visit, and Close-Out Visit Reports. Performed

qualification, initiation, monitoring and termination of investigational

sites

. Assisted with coordinated distribution of Clinical Trial Supplies,

audited, maintained and archived Sponsor's Clinical Study Records for

multiple Therapeutic Study Management areas included Metabolic and

Oncology according to Company policies and ICH Good Clinical Practice and

SOP's and Work instructions with directions from line manager and

designated clinical team members

. Assisted with designated clinical team member in preparing submissions

for Independent Ethics Committees or Institutional Review Boards (IRB) by

compiling the package of documents for the IEC/IRB and forwarding it to

either the Investigator or IEC/IRB as directed.

Clinical Support Specialist, GSK - Subcontracted for Clinforce

November 2005 - October 2006

. Provided operational support to clinical trials through worked as part of

project/study management team Plan and manage resources

. Managed clinical trials including study budget management, financial

tracking and control

. Reviewed regulatory documents received from sites before submission to

IRB and Regulatory Department, conducted operational start-up activities

to support assigned clinical project teams, interact with client and

team leadership to ensure that the projects proceeds on time and within

budget

Records & Information Management Coordinator, Quintiles, Morrisville, North

Carolina, US

November 2004 - October 2005

. Provided reference services to all departments and levels of personnel

and process incoming information, sort, classify and verify coded

material for integration into systems and operated scanning equipment

using hardware specific software. Log, QC coding, file name the scanned

image according to customer's requirements

. Coordinated work flow by assigned tasks and established procedures.

Provided guidance/direction to internal clients on customer's imaging

requirements

. Gathered and collected statistical data and prepares reports also

performed other tasks or assignments as delegate by Team Leader or RIM

Management

Document Management Specialist, GSK - Subcontracted for Clinforce, RTP, NC

United States

March 2004 - November 2004

. Audited, maintained and archived Sponsor's Clinical Study Records for

multiple Therapeutic Study Management areas according to Company policies

and ICH Good Clinical Practice and SO"s and work instructions with

directions from line manager and designated clinical team members

. Assisted in the preparation and distribution of clinical documentation

and reports (study status reports, etc.) as required and performed

assigned duties with the Study Manager direction to assisted team members

with designated administrative tasks in support of clinical trial

execution and management. Maintained clinical tracking systems

Regulatory Associate, Bertek Pharmaceuticals, Subcontracted for Clinforce,

RTP NC, US

January 2004 - March 2004

. Coordinated, assembled and shipped essential regulatory document (ERD)

packages to multiple sites

. Attended weekly internal team meetings and Sponsor teleconferences

. Fostered constructive and professional working relationships with all

internal and external team

Members/personnel so that applications were submitted and approved

expeditiously. Provided primary support for the process and maintenance

of regulatory GMP document management and training systems according with

SOP's methods and specifications

. Coordinated regulatory and pharmacy binder needs with local printing

vendor. Communicated with Study

Coordinators and Principal Investigators to request and obtain copies

of expired or outstanding documents

Clinical Support Coordinator, GSK Subcontracted for the Woolf Group,

Durham, NC, US

November 2001 - October 2003

. Performed clinical on-site monitoring activities (drive patient

recruitment, source data verification, drug

Accountability, data collection

. Assisted Clinical Study Team in start-up, execution and closeout of

clinical studies

. Assisted in maintenance and archival of study administrative files and

set up study budgets in MedFinance

(Internal tracking system) and tracked payments. Entered and updated all

study-related information in MedTrack and/or Clinical Tracking System.

Clinical Support Coordinator, Subcontracted for Staffing Alliance Staffing,

RTP, NC, US

April 2001 August 2001

. Audited, maintained, and archived Sponsor's Clinical Study Records for

multiple Therapeutic Study

Management areas according to Company policies and ICH Good Clinical

Practice, providing all necessary support in completing the collation of

all required documentation necessary for the shipping of investigational

product to the sites before patient enrollment in a given trial

. Tracked and maintained regulatory documents and maintained computer

files. Generated, audited and maintained Potential Clinical Investigator

Confidential Disclosures.

EDUCATION:

University Mariano Galvez, Guatemala, Central America, 25 Credits in

Business Administration 198-1989

Colegio Sagrado Corazon, Guatemala, Central America, Accounting Degree -

Bachelor's Degree Equivalent, 1983

LANGUAGE SKILLS:

Spanish fluent, writing and conversational; English fluent, writing and

conversational.

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