Customer Service Management

Senior budget analyst

Exceptionally well-organized, result-driven individual with the ability to

provide strong leadership & administrative support, while efficiently

managing multiple competing priorities/projects in order to forecast

fundamental needs in operationalizing clinical trials with minimal

direction.

Core Competencies & Project Management Strengths include:

Budget Preparation & Analysis Contract Administration

Feasibility & Proposal Preparation Client Relations & Internal Business

Operationalize Clinical Trials Development

Protocol Review & Interpretation Team Building & Development

Policy & Procedure Implementation

Professional Experience:

October 2008 - Present Comprehensive Clinical Development

Senior Budget Analyst (Miramar, FL)

. Manage completion of request for information (RFI) and/or request for

proposal (RFP) established by initial review of Clinical Protocol.

Provide leadership in developing thorough feasibility of

resources/site capabilities to develop/assist with proposal for

Pharmaceutical sponsored clinical trials.

. Develop and implement Budgets and Clinical Study Agreements, study

proposals, payment schedules, request and review budget/proposal from

out-sourced vendors. Forecast financial needs, including sponsor

template population, while considering contingency scenarios from a

clinical/financial stand-point.

. Plan and implement team objectives in collaboration with Clinical

Operations Team, Project Managers and Investigators to ensure

efficient/successful enrollment goals are met.

. Assist Clinical Operations/Executive Management teams reach

enrollment/financial goals by forecasting, formulating, defining and

implementing efficiencies from inception to close-out of each study.

. Able to operationalize study by allocating financial resources, while

producing quality work within tight timelines.

. Process, load and validate data via Dendrite (budget/contract activity

tracking system).

. Track, monitor and analyze data to ensure proper allocation, use and

status of funds and reconcile and resolve data discrepancies (via

Dendrite and QuickBooks).

. Well-versed in multiple project management at multiple sites by

organizing, communicating and evaluating team objectives, while

building rapport with internal/external clients, including

sponsors/vendors/per Diem staff.

. Liaise and provide support/clarification to various departments.

(e.g., Clinical Operations, Site Directors, Regulatory, Recruitment,

Screening, Census, Project Management, Finance, Client & Legal

Affairs, Clinical Services, Business Development for multiple sites)

. Set-up/participate in Bid Defense and/or Teleconferences with

internal/external clients to obtain/provide clarification and/or

operationalize/recommend efficiencies.

. Host/Present bi-quarterly department specific presentations (e.g.,

MAGI Conference, Friendly Debates, Negotiation, Leadership, Client &

Legal Affairs, Customer Service, Time Management Workshops, and

Harmonization of Processes).

. Host/Present to various Clinical Site and Finance team members on

scope of services provided by Client & Legal Affairs, including

periodic updates as it relates to process changes/implementation.

. Manage/Request access to Budget & Contract SharePoint sites.

. Corporate Headquarters Champion for company Wellness Program.

. Peer Review of Senior Analysts' budgets with suggested

recommendations/feedback for consideration.

. Review & Mentoring of Junior Analysts' budgets with suggested

recommendations/feedback for consideration.

May 2008 - August 2008 Segal Institute for Clinical Research

Lead Clinical Research Coordinator

(North Miami, FL)

. Reviewed and evaluated all Clinical Protocols with team to determine

feasibility, including resources/site capabilities of conducting the

study. Provided leadership to team by maintaining knowledge of all

protocols being conducted at main and satellite unit (travel

required).

. Supervised/trained/guided Clinical and Data Research Coordinators.

Prepared guidelines for specific role assignments for research

coordinators, raters, and lab techs.

. Facilitated/oversaw study activities associated with implementation,

monitoring and termination.

. Served as a liaison between Principal Investigator (P.I.), Sponsor and

contract research organizations (CRO). Assisted in resolution of

clinical and operational challenges.

. Coordinated and organized administrative activities for the pre-study

assessments, study initiation visits, and monitoring visits with the

sponsor or CRO.

. Communicated research participant issues promptly and effectively to

P.I. and/or leadership personnel.

. Participated in internal monthly Lead CRC and study related meetings.

Occasional travel required.

. Maintained clinical competence through continuing education including

BLS, IATA and HIPAA.

. Adhered to all internal policies, Good Clinical Practice, ICH and FDA

guidelines.

. Tracked, monitored and analyzed data collection and quality.

. Successfully managed multiple studies by organizing, communicating and

evaluating team objectives, while building rapport with

internal/external clients.

. Liaised and provided support/clarification to Clinical Operations,

Site Directors, Regulatory teams.

. Set-up/participated in teleconferences with internal/external clients

to obtain/provide clarification and/or operationalize/recommend

efficiencies.

November 2007 - April 2008 Sunrise Clinical Research

Clinical Research Coordinator (Hollywood,

FL)

. Reviewed all Clinical Protocols as assigned for multiple study

management.

. Aided in facilitating all activities associated with implementation

and termination of studies.

. Collaborated in coordination/organization of administrative activities

for pre-study assessments, study initiation visits, and monitoring

visits with the sponsor or CRO.

. Reported research participant issues promptly and effectively to P.I.

and Site Director.

. Abided by all internal policies, Good Clinical Practice, ICH and FDA

guidelines.

. Collected, transcribed and verified quality of source documents and/or

eCRF data.

. Provided support to Clinical Operations, Site Directors and Regulatory

teams.

February 2007 - November 2007 Medical Research Unlimited

Clinical Research Coordinator (Hialeah,

FL)

. Reviewed all Clinical Protocols as assigned for multiple study

management.

. Contributed with facilitation of activities associated with

implementation and termination of studies.

. Assisted in coordinating and organizing administrative activities for

the pre-study assessments, study initiation visits, and monitoring

visits with the sponsor or CRO.

. Alerted P.I. to any research participant issues promptly and

effectively.

. Continued education via BLS, IATA, HazMat and Phlebotomy training.

. Followed all internal policies, Good Clinical Practice, ICH and FDA

guidelines.

. Collected, recorded and confirmed quality of source documents and/or

eCRF data.

. Rendered support to P.I. and Lead Clinical Research Coordinator.

July 2005 - February 2007 BankAtlantic Administrative

Assistant (Plantation, FL)

November 2004 - July 2005 Full-time College Student MDC / BCC

November 2003 - November 2004 South Florida Medical Research Asst

Office Admin (Aventura, FL)

May 2000 - November 2003 Uro-Medix Administrative Assistant

(Aventura, FL)

November 1996 - April 2000 Humana, Inc. Workers' Compensation &

Utilization Management

Education / Professional Certifications:

MAGI Member Since: 05/2012

Phlebotomist Issue Date: 04/28/2007

License # 698775476B Expiration: 05/30/2010

BLS Certified (Basic Life Support) Issue: 10/12/2007

Expiration: 10/2009

IATA Certified (SAF-T-PAK) Issue: 09/24/2007

Expiration: 09/24/2009

HazMat Certification Issue: 07/2008

Physician Assistant Studies November 2004 - July 2005

American Senior High School June 1994

Certified Nursing Assistant Issue Date: 10/12/1993

Certificate #: 109**********

Technology:

. Microsoft Office 365 with advanced knowledge of Word, Excel, Outlook,

and PowerPoint.

. Internal Database / Applications: Dendrite, SharePoint; Moderate

knowledge of Intuit QuickBooks.

References Available Upon Request

Contact this candidate