Project Sales Representative

Ashlee M. Boyce

**** ********* ****** *** ***.*07 Raleigh, NC 27616 919-***-****

*********@*****.***

QUALIFICATIONS

. Clinical research professional with over five years' experience in

Phases I-IV

. Excellent communication and organizational skills, with the ability

to manage multiple projects simultaneously and carry these projects

to fruition

. Knowledgeable of Good Clinical Practices and ICH Guidelines

. Extremely competent in contract negotiations

. Software: Operating Systems (Windows); Data Analysis (SPSS);

Database Management (Access and SharePoint); Spreadsheets (Excel);

Presentation Graphics (PowerPoint); Bibliographic Search; CTMS

(IMPACT and Siebel)

EDUCATION

East Carolina University

Master of Arts; Communication December 2007

Health Communication

Bachelor of Arts; Communication May 2006

Concentration; Public Relations

Minor; English

THERAPEUTIC EXPERIENCE

Oncology

Women's Health

Depression

Ethnic Health Disparities

End of Life Care

Palliative Care

WORK EXPERIENCE

2013-2014, Quintiles Contract Position, Durham, NC

Site Identification Specialist

Duties

. Distributed, tracked, and negotiated the Confidential Disclosure

Agreements (CDAs) with assistance from Management / QLegal as

appropriate.

. Utilized various sponsors' fallback language to complete CDA

negotiations in a timely manner.

. Designed, distributed, tracked, and reviewed Site Information Forms

(SIFs) for completeness, site capability, and availability.

. Managed template documents for Confidential Disclosure Agreements

(CDAs) and Site Interest Forms (SIFs).

. Provided project progress reports to Internal and External project

teams including department management.

. Took independent responsibility for assigned site identification

projects.

. Took lead on projects with increased protocol complexity, site numbers

and/or customer SOPs or processes.

. Utilized historic site performance metrics, cluster sites, partner

sites, feasibility data, and other data to identify potential sites.

. Reviewed changes made to Site ID Manual.

. Submitted and reviews investigators for quality assurance status as

applicable.

. Tracked all project activities in Quintiles Database system.

. Contacted Feasibility, Medical Scientific Services, and Clinical

Operations Leaders to develop plans for identifying potential sites

and processes for assigned projects.

. Reviewed and tiered sites for contact based on historical site

performance and other required criteria.

. Entered new sites and investigators into the Quintiles Database,

reviewing entries for duplicates.

. Transferred applicable data and documentation to Clinical Operations.

. Maintained departmental files, including site list and other project

materials as required.

. Responded to site questions about assigned studies in a timely manner.

2011-2013, INC Research, Raleigh, NC

Project Specialist

Duties

. Performed in-house monitoring of clinical trials to ensure sponsor and

investigator obligations were being met and compliant with protocols

and local regulatory requirements and ICG guidelines.

. Performed remote source document verification and query resolution in

a timely manner.

. Performed regulatory documentation collection and review according to

Essential Regulatory Document Guidelines (ERDG) and Trial Master File

(TMF) Plan. May conduct secondary review of Essential Regulatory

Documents. May serve as project representative for internal and

external TMF audits.

. Distributed, tracked, and negotiated Confidential Disclosure

Agreements (CDAs), with assistance from INC Legal as appropriate.

. Provided weekly feasibility progress reports to Internal and External

project teams.

. Assisted Project Lead on projects with increased protocol complexity,

site numbers and/or customer SOPs or processes.

. Utilized historic site performance metrics, cluster sites, partner

sites, feasibility data, and other data to identify potential sites.

. Utilized designated clinical trial management system to track and

process clinical trial information, (e.g., regulatory documents,

enrollment, SAE/ AEs, protocol deviations, supplies, IRB re-approvals,

data queries) in order to provide analysis of information to Project

Leader (PL).

. Updated Project Leadership and CRAs of sites and study status.

Prepares and presents analysis of project level details such as

enrollment, regulatory document collection, and data

collection/review. Contacted site staff for critical information.

. Assisted the PL with projection and validation of financial backlog

and project realization on assigned projects. Includes review of

regular financial reports and analysis of upcoming project events to

verify financial forecasts.

. Recorded the status of Key Performance Indicators (KPIs) in assigned

systems, with input and oversight from

the assigned PL. Assessed and communicated KPIs for associated job

tasks to PL with proposed action plan.

. Served as primary customer contact when PL is out of the office.

Seeks input from Project Director for customer support.

. Scheduled and attended internal and external team meetings. Prepares

and distributes all meetings minutes for both internal and external

meetings. Follows-up with team members on action items from meetings.

Attended clinical monitoring staff meetings, project team meetings,

clinical committees, and clinical training sessions according to the

project communication, project management, monitoring and/or training

plans.

. Prepared for and participated in Kick-Off Meetings, Quick Start Camps,

and Quality Finish Camps.

. Assisted in the development of informed consent form (ICF) using

project specific knowledge and performs in-house Case Report Form

(CRF) review.

. Assisted in the development of the Cohort Allocation Plan using

project specific knowledge and templates.

. Served as administrator of shared workspace for assigned projects.

2006-2011, East Carolina University, Greenville, NC

Clinical Research Coordinator, 2009-2011

Duties

. Responsible for participant recruitment and enrollment.

. Provided administrative and scheduling support to study

interventionist.

. Monitored participant progress throughout all phases of research

projects.

. Assisted Principal Investigator in intervention protocol development.

. Maintained study website.

. Compiled educational materials for community presentations.

. Participated in the delivery of educational programs in community

settings.

Executive Assistant to AVC of Campus Living, 2008-2009

Duties

. Trained and supervised clerical staff.

. Planned numerous campus events such as Open House and Move-In.

. Demonstrated administrative experience with higher education policies,

procedures, and organizational structure.

. Used knowledge of extensive campus network of administrative offices

and contacts to coordinate academic personnel actions.

. Independently organized and coordinated a variety of tasks and

projects in a high volume, production-oriented unit, including follow-

up as needed.

. Interacted professionally and courteously with diverse personalities

within and outside of the University, using tact, diplomacy, and

flexibility.

Adjunct Instructor of Business and Professional Communication/Public

Speaking, 2008-2009

Duties

. Demonstrated a commitment to the mission and vision of the university.

. Continuously developed learning and teaching methods to meet the

diverse learning styles and needs of the students.

. Collaborated voluntarily and energetically with colleagues in the

academic discipline to develop effective learning experiences.

. Integrated intercultural experiences into the curriculum.

. Made effective use of appropriate technology.

. Committed to ongoing educational and professional growth.

. Engaged fully in course, discipline, and program development.

Research Study Coordinator/"Insight-Plus: A Cognitive Behavioral

Intervention Pilot Study for Pregnant African-American and Caucasian Low

Income Women with Depressive Symptoms"

2007-2007

Duties

. Planned and facilitated Insight-Plus groups.

. Conferred with potential participants to communicate objectives of

program.

. Evaluated and selected program participants according to specified

criteria.

. Collected and evaluated clinical data.

. Tested the feasibility of the intervention and the control group

effectiveness of the recruitment and retention strategies.

. Assisted with report writing.

Research Assistant - School of Communication, 2006-2007

Duties

. Managed multiple projects simultaneously and carries these projects to

fruition.

. Possessed strong problem-solving skills and the ability to exercise

sound judgment when managing conflicting priorities.

. Maintained confidentiality in dealing with sensitive issues.

. Interpreted, synthesized, and analyzed data using scientific or

statistical techniques.

. Modified and planned research experiments, procedures, tests, or

survey instruments.

. Wrote and edited material for publication and presentation.

. Identified and recruited study participants.

. Extracted and compiled a broad range of data from a variety of written

sources, personal contacts and/or databases selected independently.

. Responsibility for basic troubleshooting and repair or manipulation of

data using published software.

2007-2007, GlaxoSmithKline, RTP, NC

Marketing Consultant/Campus Consumers Program, 2007-2007

Duties

. Met or exceeded product sales objectives for assigned portfolio of

products.

. Maintained an in-depth and sophisticated knowledge of specific

healthcare issues, products, and diseases.

. Maintained an expert product knowledge base including patient

education, consumer education, and factors influencing the market

environment.

. Used approved promotional materials to support marketing message.

. Established and maintained objectives for geography in consultation

with district management to assure proper planned actions.

. Created effective call plans that included: who to contact, how

frequently to contact them, and what products to focus on for each

call.

. Made judgments about the appropriate message for each consumer.

. Continuously prospected for appropriate new customers; communicates

opportunities, competitive activity, and business events to the area

Sales Representative.

2005-2005, North Carolina General Assembly, Raleigh, NC

Intern, 2005-2005

Duties

. Assisted legislator in preparation of proposed legislation.

. Conducted research into subject of proposed legislation and developed

preliminary draft of bill.

. Attended committee meetings and prepared reports of proceedings.

. Spoke with lobbyists, constituents, and members of press to gather and

provide information on behalf of legislator.

. Analyzed voting records of other legislators and political activity in

legislator home district to derive data for legislator consideration.

. Maintained liaison with government agencies affected by proposed or

pending legislation.

. Assisted in campaign activities and drafted speeches for legislator.

. Wrote press releases on the legislator's behalf.

. Established rapport with radio, television, and print media contacts.

. Organized a fundraiser on behalf of the legislator.

. Structured a campaign with Together Rx for uninsured people in the

state.

PROFESSIONAL DEVELOPMENT

Training

. Phase I Oncology

. Solid Tumors

. Good Clinical Practice

. Drug Development Process

Contact this candidate