Manager Medical

DAYON A. FLETCHER

**** ********* ******** *****

Lithia, FL 33547

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SUMMARY/ WORK EXPERIENCE:-

Clinical Research Associate/ Coordinator:-

6/02 to present Cosmetic and Reconstructive Surgery Center

Dr. Lewis Berger and Dr. Melanie Aya-ay

2901 St. Isabel Street / 2C

Tampa, Florida 33601

Clinical Research Study Associate / Coordinator • I worked independently On

Site and Off Site for two Principal Investigators contracted by three major

Sponsors (Allergan, Sientra and Mentor) seeking FDA approval for usage of

their product (Breast Implants) within the United States. •This included working

closely with both Investigators maintaining proper record keeping for 11 different

Breast Implant Study Protocols. • Monitor all aspects of the Clinical Trial

•Conduct Pre-Study, Initiation and Close Out Site Visits •Verify and completing

Case Report Forms (CRF) against source documents. • Manage Screening Logs

and Enrollment Logs. •Maintain Regulatory Binders in preparation for Sponsors

to review. •Active communication with Sponsors and their Project Team Leads.

•Monitor and updating Investigators product Device Accountability Logs (DAL).

•Consenting patients with the appropriate Informed Consent (IC) based upon the

Study Protocol prior to implantation •Coordinating the appropriate tests for study

patients required at certain intervals per Study and FDA Regulations…ex. MRI's,

• Submitting data and Compliance Reports on behalf of the Sponsors. •

Responsible for orchestrating and supervising quarterly audits for the Study

Protocols • Medical Terminology. •Complete appropriate Clinical Training as an

educational and learning tool. •Maintain the clinical knowledge to ensure the

Investigators are practicing GCP guidelines. •I am also involved with submitting

the appropriate documents required annually by the FDA to the IRB for Renewal.

•Completing outstanding Data Clarification Forms (DCF’s).

•Ensuring all applicable AE’s are properly documented, completed and submitted

in a timely fashion. •As the home based Research Coordinator I was privileged to

be involved first hand with the patients at their initial, follow up and post op study

appointments this included all Cosmetic and Breast Reconstructive patients.

•Obtaining the correct demographic information, medical history and physical,

medication log, pathology reports, sonograms, MRI’s, •Excellent written,

organizational and communications skills. •Monitored approximately 10-15 Off

Site Visit monthly on behalf of the Sponsors •Traveled for additional educational

training in order to effectively conduct and communicate any changes to the Study

Protocols •Perform other administrative duties / tasks not necessarily related to

the study.

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12/00 to 3/02 The Plastic Surgery Group, PC.

650 Northern Boulevard

Great Neck, NY 11021

Assistant Office Manager / Surgical Scheduler:- • All aspects of scheduling

surgery for the hospital; hospital registration. • Responsible for mailing all

surgical correspondence. •Liaison between hospital / patient and physician.

• Phone screening. •Patient coordination with reference to surgery. • Training of

new front office staff. • Scheduling surgery, pre-operative and post- operative

surgical counseling. • Insurance verification. • A cosmetic consultant. • FMLA

and Disability liaison. • OSHA training.

5/97 to 9/00 St. Luke’s Roosevelt Hospital

1000 10th Avenue

NYC 10019

Assistant Office Manager and Pre-Certification Manager:- • Front Office Staff

Management of 5 •Managed a Clinical Staff of 3 Residents, 5 Attending

Physicians, 2 Nurses, 3 Fellows, and 1 Physician Assistant. • Assist in

resolving patient difficulties. •Handles practice management in the absence of

Business Manager. • Controls patient schedule and office flow. • Resolve patient

issues. •Staff training. •Assist with some aspects of budget proposals.

• Act as liaison between several hospitals with regards to setting up Operating

Room Procedures etc.

Pre Certification Representative:-• Handles prior approval for all procedures

and office visits, all insurance query (from Self Pay to No - Fault or Workers

Compensation), medical necessity letters for insurance carriers to ensure payment.

• Respond to Lawyers medical request. • Resolved billing questions. • Review

medical dictations and super bills. • Arrange payment plans for self pay patient.

EDUCATION

LONG ISLAND UNIVERSITY

Degree ---Bachelors of Science

Degree -- Bachelors in Hospital Administration

Clinical Research Associate Certification In progress)

SYSTEMS EXPERIENCE/IT Skills

•Windows XP •MS Word •Power Point •Excel •Inform •Nextech

•Outlook •Medical Manager

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5822 Heronview Crescent Drive, Lithia Fl 33547.

Tel: 813-***-**** / Cell: 813-***-**** / e-mail *************@*******.***

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