Customer Service Project

Lisa Sellers

** ******* ****** ( Lynn, Massachusetts 01904

617-***-**** (home) ( ***********@*****.***

Senior Clinical Researcher

Analytical and collaborative professional with 8 years of experience,

including recent research success in biotechnology and medical clinical

areas. Role of Project Coordinator on four (4) medical device studies.

Played key role in large-scale clinical studies with up to 800 subjects,

compiling and analyzing data, generating reports, and conveying results to

necessary business and regulatory bodies. Offer consistent record of

successful project leadership, ensuring execution of initiatives on time

through effective collaboration and cross-functional communication. Known

as self-starter who takes initiative to complete tasks overlooked by

colleagues. Often called on to lead core team meetings and mentor peers.

Clinical Research ( FCRA Reports ( Statistical Reports ( Final Study

Reports ( Project Management

Data Gathering, Analysis, & Management ( Action Plan Coordination ( Cross-

functional Communication

Regulatory Compliance ( Spent most time working on Phase II and Phase III

Trials ( Budgeting ( In-House Monitoring ( Site-Level Monitoring ( Process

Improvement( Work with MS Project when planning trials

Scheduling ( Customer Service ( Performance Management ( Team Leadership &

Mentoring

Professional History

Medtronic, Inc., Danvers, Massachusetts ( 11/2006-10/2012

Clinical Research Specialist (2010-2012)

Associate Clinical Research Specialist (2008-2010)

Project Coordinator (2006-2008)

Performed as Project Coordinator from 2006-2008 for AMEthyst study with 800

subjects, Associate Clinical Research Specialist in 2008 for Complete SE

Iliac Registry with 60 subjects, and Solid Lead from 2008-2012 for Complete

SE SFA Study with 195 subjects. Compiled, reviewed, and analyzed data;

gathered, tracked, and verified information from multiple sources.

Generated reports, statistics, timelines, tables, graphs, correspondence,

and presentations using applicable software. Ensured that all study data

was entered properly to enable accurate report generation. Obtained missing

documentation from sites using strong relationships with research

coordinators.

Gathered clinical data for submission to MDT regulatory for all study

reports, including investigator list, serious adverse events, and adverse

events. Ensured that all necessary reports were sent to FDA in timely

manner. Liaised between sites, FCRAs, and BDM, ensuring review and

completion of DCFs within project timelines. Obtained reports from FCRAs,

reviewing data from their site visits and returning reports for edits or

approval. Monitored device reconciliation during enrollment. Fostered

relationships with colleagues, which were helpful in compiling query

documentation during end of program. Maintained and updated departmental

policies & procedures as mandated by organization. All this information

was compiled and prepared for the 510(k) submission to the FDA for the

Complete SE Iliac Study.

. Initially hired as Project Coordinator; earned promotion to Associate

Clinical Research Specialist within 1 year due to completing enrollment

and working with FCRAs to close out all 30+ sites; wrote final study

report after all sites were closed and all data was collected.

. Selected as only CRS trusted by management to lead core team, safety,

CEC, and monitor meetings for Complete SE SFA study due to leadership

abilities and clinical studies knowledge. This study was the only

Medtronic study in Danvers that maintained relationships with OUS sites,

as well as US Sites.

. Enabled notifications of DOP and SOP updates to be pushed to clinical

department on regular basis by collaborating with California office to

merge systems.

. Designated to author monthly newsletter on Complete SE Iliac and Complete

SE SFA studies that was published and read globally by employees to

maintain awareness of company progress.

Lisa Sellers ( Page 2 ( ***********@*****.***

Medtronic, Inc. (continued)

. Mentored associate clinical research specialists and project

coordinators, thus enabling study progress rather than waiting on

management for guidance, after gaining in-depth knowledge during personal

involvement in clinical trials. Able to present necessary guidance and

presentations to other CRS's, other CTL's and other necessary individuals

that are involved in the trial.

. Approved FCRA expense budget and then invoicing and processed it forward

to payroll department for payment. Had and maintained excellent

communication with other departments throughout the country.

. Played key role in PMA device becoming only stent that obtained market

approval in Danvers for Medtronic Danvers. I wrote the clinical portion

of the Final Study Report that was sent to the FDA.

. Defined as a strong team player that is always there to support, yet can

offer that leading touch as needed.

. Commenced closing of all site files for AMEthyst study while colleagues

were busy with other tasks, earning recognition from clinical director

for taking initiative.

. Set up Trial Master Files according to DOP and SOP procedures.

Spaulding Rehabilitation Hospital, Medford, Massachusetts ( 8/2004-10/2006

Patient Service Representative

Administered patient check-in and paperwork as well as prepared patient

charts for therapist. Booked and maintained therapists' schedules,

including appointments for physical, occupational, and speech/language

therapies. Handled patient co-pays and balanced expense sheet each day.

Answered patient inquiries via phone at outpatient center. Proactively

contacted patients to ensure proper booking of appointments.

. Enhanced patient experience through establishing positive rapport with

them, remembering their individual names, and maintaining friendly

environment.

. Earned special achievement recognition, including Customer Service Award

and Outstanding Office Award.

Education

Master of Business Administration

Minor in Project Management

DeVry University

Chicago, Illinois

Bachelor of Arts, Business Administration

Penn State University

Altoona, Pennsylvania

Professional Affiliation

Association of Clinical Research Professionals (ACRP)

Member

Recognition

STAR OF EXCELLENCE

Individual Excellence in Support of a Team Effort in a Clinical Trial

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