Management Technician

Keston E. Ettienne

P.O. Box *****, Tampa, FL ****6

813-***-**** (mobile)

813-***-**** (office/fax)

abnper@r.postjobfree.com

THERAPEUTIC EXPERIENCE

Cardiovascular: Coronary Artery Disease, Hyperlipidema, Hypertension

Dermatology: Acne

Device: Insulin Inhaler, Breast Implants, Orthopedic Fixation Device, Pain Pump

Endocrinology: Type I and Type II Diabetes

Genitalurology: Erectile Dysfunction

Infectious Disease: HIV (nosocomial infection), Influenza, Post Surgical (nosocomial

infection)

Nephrology: Dialysis

Oncology: Small Cell and Non Small Cell Lung Cancers, Mesothelioma, Ovarian

Cancer, Breast Cancer, Gastrointestinal Cancer, Prostate Cancer

Orthopedics: Fracture Repair

Pain Management: Pain Pump, Post Surgical Pain

Psychiatry: Bipolar Disorder, Sleep Disorder, Depression, Anxiety

Respiratory: COPD

Rheumatology: Osteoarthritis, Rheumatoid Arthritis

Experience as Study Coordinator:

Small Cell and Non Small Cell Lung Cancers, Mesothelioma, Ovarian Cancer, Breast

Cancer, Gastrointestinal Cancer, Prostate Cancer, Sarcoma

Phases of Experience: Phase I – IV

PROFESSIONAL EXPERIENCE

President/Co-Owner; Contract Clinical Research Associate

K & A Clinical Research Services, LLC, Tampa, FL

June, 2006 to Present

Clients:

i3research: Eli Lilly (Jul ’07-Mar ’09)

eReady: GSK (Jun ’06-Jul ’07)

PharmaForce: Genentech (Aug ’07-Aug ’08)

Pharmanet: Abbott Labs (Jan ’07-Aug ’07)

Omnicare: Gynzyme (Jun ’06-Jun ’07)

Bayer (Jun ’06-Jan ’07)

● Investigator training

● Full site management including site selection, initiation, routine monitoring, and

closeouts visits

● SAE management, drug accountability, and regulatory management

● Promote and maintain adherence to ICH/GCP guidelines and FDA regulations

● Facilitate patient recruitment and development and deployment of site recruitment

plans

● Extensive utilization of Electronic Data Capture and other computer-based programs

Clinical Research Site Manager (Home-based)

Kforce, Inc., Tampa, FL

January, 2005 to June, 2006

● Investigator training

● Full site management including selection, initiation, routine monitoring, and closeouts

● SAE management, drug accountability, and regulatory management

● Promote and maintain adherence to ICH/GCP guidelines and FDA regulations

● Facilitation of patient recruitment and development and deployment of site recruitment

plans

● Extensive utilization of Electronic Data Capture and other computer-based programs

● Preparation and distribution of study materials including CRFs, study reference

manuals, and monitoring guidelines

● Participation in investigator meetings

● Collection and verification of essential regulatory documents and site personnel

training records

● Performed source document verification and drug accountability

● Coordinated the preparation and reporting of Adverse Events

● Reviewed CRFs received in-house and performed data clarification functions

● Conducted study closeout activities

● Prepared site visit reports and follow-up letters

● Actively communicated with clinical team members; also, participated in team

meetings and updates

● Mentored and trained new Clinical Research Associates

Clinical Research Associate (Home-based, Part-time Consultant)

Clinical Monitoring Services Group, Atlanta, GA

December, 2003 to January, 2005

● Full site management including routine monitoring, and closeouts

● SAE management, drug accountability, and regulatory management

● Promote and maintain adherence to ICH/GCP guidelines and FDA regulations

● Extensive utilization of Electronic Data Capture and other computer-based programs

Contracts and Clinical Trials Budget Specialist, Clinical Trials Supervisor, Clinical Trials

Coordinator

H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL

May, 1997 to January, 2005

● As a Contracts and Clinical Trials Budget Specialist, duties included budget

negotiations/analysis and contract negotiations for investigator initiated and

pharmaceutical company-sponsored trials.

● As a Clinical Trials Supervisor, supervised a Department of Defense-sponsored

Early Detection of Lung Cancer Screening Clinical Trial (Spiral CT vs CXR) with an

enrollment of over 1,100 study subjects. Other responsibilities included IRB and DOD

regulatory file maintenance, study audits, data management, and phlebotomy and

specimen processing. Additional management duties included payroll processing, staff

evaluations, and light accounting operations.

● As a Clinical Trials Coordinator, coordinated multiple clinical trials from Phase I to

Phase IV within the Thoracic and Sarcoma Oncology Programs. In addition, assisted

with enrollment in Clinical Investigation Department Research studies through direct

and indirect patient encounters, which included discussing requirements for clinical

trials directly with patients via phone, email, fax, and in person. Received and

responded to inquiries from subjects concerning a variety of medical, personal, and

administrative matters determining the general nature of the inquiry and independently

responding to all questions. Maintained records of treatment of pre and post-operative

evaluations and input data into computerized database. Assisted in the development of

standard response templates for patient inquiries. Trained new staff and/or volunteers

who may have been required to fill in during periods of absences. Prepared study

start-up packets and provided assistance with protocol and source document forms

preparation. Created and maintained multiple clinical study tracking databases.

PUBLICATION(S)

ZD1839 ('Iressa') as a single agent for the treatment of metastatic non-small-cell lung

cancer, 2002.

Abstract: Purpose: To assess the response rate and tolerability of ZD1839 in a

population of metastatic non-small-cell lung cancer (MNSCLC) patients at MCC in

response to increasing demand for compassionate use supplies

Author(s): John C Ruckdeschel, George Simon, Scott Antonia, Eric Haura, Charles

Williams, Henry Wagner, Caio Rocha Lima, Keston Ettienne, Jeannie Vaughn, Gerold

Bepler, H Lee Moffitt Cancer Ctr & Research Inst, Tampa, FL

EDUCATION

B.A. Interdisciplinary Sciences, Biology Candidate, December, 2009

University of South Florida, Tampa, FL

SPECIALIZED EXPERIENCE

Dialysis Technician (2 yrs.); Sterile Processing Technician (3 yrs.); Laboratory

Technician (3 yrs.); Phlebotomist (3 yrs.); Logistics Specialist (6 yrs.-U.S. Navy)

TECHNICAL/EDC EXPERIENCE

Microsoft Office, Lotus Notes, Oracle Clinical, InForm, etrials, eclinical, I-net, and

numerous other proprietary software

Hamilton Rating Scale, WHO MDI, DASS, and other Depression Screening Tests

REFERENCES

Available upon request

Contact this candidate