Lana L. Levi

310-***-****

accxx6@r.postjobfree.com

To Whom It May Concern:

My name is Lana Levi; I have over 13 years of Clinical Research experience and over 22 years of

Medical Clinical experience working in a world renowned healthcare organization, private practices

and research groups in Cardiology, Sleep Medicine, Psychiatry, Memory Disorders, CNS, Quality of

Life Registry and Dermatology. I am open for new career opportunities in all medical specialties and

will learn for future advancement.

I am experience Coordinator and work independently or as a team player within the group, providing

study coordination including screening of potential patients for protocol eligibility, presenting non-

medical trial concepts and details, and participating in the informed consent process, oversight of all

studies to clinical research personnel within the group, and supervision of research staff. Plan and

coordinate strategies for increasing subject enrollment, subject adherence to study protocol, efficient

and highly professional, experienced in training personnel (CRC’s, Research Assistants, Residents, and

Volunteers), identify new research opportunities, developing of Standard Operational Procedures and

Sours Documents. Coordinated all aspects of Industry Sponsored Clinical Trials, NIH and NARSAD

clinical research Phase II, III and IV. Compliant with all federal and local agencies including the Food

and Drug Administration (FDA) and local Institutional Review Board (IRB). Accurate in timely data

collection, documentation, entry, and reporting including timely response to sponsor queries. Schedules

and participates in monitoring and auditing activities.

In previous positions was in charge of feasibility reports, site selection/initiation visits, regulatory,

budgeting duties and stuff selection. Trained and certified on research practices using Good Clinical

Practice (GCP) guidelines. Maintain strict patient confidentiality according to HIPAA regulations and

applicable law. Participate in required training and education programs and coordinated travels for

Investigational meetings and ream training post meeting

As of June 29, 2012, last place of employment, Department of Psychiatry and Behavioral

Neurosciences at Cedars Sinai Medical Center closed all psychiatry programs and I am therefore

looking for a new place of employment.

I am open for new career opportunities and would be grateful if you contact me for an interview as a

possible candidate.

Enclose is a copy of my CV for your consideration.

Bachelors of Science, Nursing/FMG

Foreign Medical Graduate

LANA L. LEVI

accxx6@r.postjobfree.com 310-***-****

Summary of Qualifications

Over 13 years of clinical research experience and over 20 years of medical clinical experience working in a world

renowned healthcare organization, private practices, and private research groups. Familiar with Phase II, III and IV and

pharmaceutical Clinical Trials. Ability to work under pressure and meet deadlines; work independently and self

directed; pay attention to detail, identify and resolve problems; work as a member of a multi disciplinary team. Worked

with Fortune 100 pharmaceutical companies such as Merck, Pfizer, Astra Zeneca, Johnson & Johnson and others.

• Highly experienced in planning and directing • Partner & communicate effectively with

clinical trials for Merck, Pfizer, Astra Zeneca, subjects, research team, IRB’s, and

Johnson & Johnson, Cyberonics, Forest sponsors.

Research Institute, Dainippon Sumitomo

Pharma America, Inc., Allergan, Lythera, and

• Expertise in regulatory submissions,

more

reporting, confidentiality, subject

• Strong leadership, organizational, analytical,

recruitment, & monitor & audit visits.

computer, marketing & medical terminology

abilities

A results oriented and high energy Clinical Research Coordinator who consistently meets and exceeds key stakeholders’

expectations and organizational goals. Committed and dedicated professional working towards achieving the highest

standards of care and performance. Bi lingual in English & Russian.

Accomplishments include being the key clinical coordinator on over 70 studies within the specializations of Cardiology,

Sleep Medicine, Psychiatry, CNS, Memory Disorders, and Quality of Life Registry and Dermatology.

A single proprietor of “Color Fun” 2 locations, centers for unfinished ceramics designs and coordination of events, marketing.

Licensed Esthetician and beauty events coordinator, marketing and public relations at Multiple European Esthetician

Institutes.

Professional Experience

Skin Care and Laser Physicians of Beverly Hills March to September

2013

Los Angeles, California (Temporary position)

Research Lead/Regulatory/ Research and Patient Care Coordinator

Lead Coordinator on Phase II and III and IV clinical trials in facial aesthetics responsible for screening of potential patients for

protocol eligibility. Planning, preparing, assembling trial specifics & training research team assigned trial. Coordinated

Memory Disorders and Patient Outcome Registry. Responsible for contact with study participants and families, recruitment

and advertising, scheduling, ratings on study related assessments, training and management of new staff and day to day

operations. Ensures the efficacy of the study through accurate documentation and maintenance of all study related procedures,

processes, and events. Managing every aspect of a clinical research trial from feasibility, site selection, initiation to close-out,

subject selection, pre-screening/screening, worksheets/documents & case report forms (eCRF's), collecting & reporting

adverse. Creating protocol specific source documents, data, subjects visit & all related information, schedule. Ability to work

under pressure and meet deadlines; work independently and self directed; pay attention to detail, identify and resolve

problems; work as a member of a multi disciplinary team. Developed Research Standard Operational Procedures; in charge of

recruitment and advertising. Trained and certified on GCP.

Cedars Sinai Medical Center, Los Angeles, California May 2006 June

2012

Clinical Research Coordinator

Department of Psychiatry & Behavioral Neurosciences

Responsibilities include screening of potential patients for protocol eligibility, presenting non-medical trial concepts and

details, and participating in the informed consent process, oversight of all studies to clinical research personnel within the

group, and supervision of research staff. Plan and coordinate strategies for increasing subject enrollment, subject adherence to

study protocol, efficient and highly professional, experienced in training personnel (CRC’s, Research Assistants, Residents,

and Volunteers), identify new research opportunities, developing of Standard Operational Procedures and Sours Documents.

Management of all aspects of NIH and NARSAD clinical research studies and Industry Sponsored Clinical Trials, Regulatory

documents, IRB submissions, and training, lead team meetings and monitoring visits pre and post studies. Trained on all

federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Experience in accurate in timely data collection, documentation, entry, and reporting including timely response to sponsor

queries. Schedules and participates in monitoring and auditing activities.

I work with the Institutional Review Board (IRB), local and central, on initial submissions and Adverse Events, Serious

Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.

In previous positions was in charge of feasibility reports, site selection/initiation visits, regulatory, budgeting duties and stuff

selection. Participated in developing office research Standard Operational Procedures (SOP). Maintain strict patient

confidentiality according to HIPAA regulations and applicable law. Participate in required training and education programs and

coordinated travels for Investigational meetings and team training post meeting.

Pacific Sleep Medicine Services, Los Angeles, California September 2000 –

February 2006

Pacific Sleep Medicine specializes in effectively diagnosing sleep disorders. As a leading provider of sleep medicine and

related

Medical equipment, they offer patients and referring physicians a comprehensive program designed to help those suffering

from

various sleep disorders. Organization conducted many sleep related and neurology clinical trials.

Lead Clinical Research Coordinator/Regulatory Specialist

Responsible for planning and directing site operations, protocol assessment, initiation and planning activities related to a

variety of pharmaceutical clinical trials. Organized and implemented pre and post initiation activities including subject

recruitment enrollment and study visits. Maintained strictest confidentiality standards. Accomplishments include over 34

successful clinical trials. Responsible for submitting all documentation of study personnel and data for regulatory approval.

Responsible for taking patient’s vitals, drawing blood, and documenting medical history, screening of potential patients for

protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process,

oversight of all studies to clinical research personnel within the group, and supervision of research staff. Plan and coordinate

strategies for increasing subject enrollment, subject adherence to study protocol, efficient and highly professional, experienced

in training personnel (CRC’s, Research Assistants, Residents, and Volunteers), identify new research opportunities, developing

of Standard Operational Procedures and Sours Documents. Management of all aspects Industry Sponsored Clinical Trials, IRB

submissions, and training, lead team meetings and monitoring visits pre and post studies. Trained on all federal and local

agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Experience in

accurate in timely data collection, documentation, entry, and reporting including timely response to sponsor queries. Schedules

and participates in monitoring and auditing activities.

SDI Future Health, Inc., Los Angeles, California July 1999 – September

2000

SDI, Inc. was founded in 1994, has 100 employees and operates sleep disorder testing facilities in seven states.

Coordinator

Traveled to clinics throughout Southern California recruiting subjects for sleep studies to determine sleep disorders.

Responsible for diagnosing and prescribing devices for sleep disorders. Advised patients on possible other effective

treatments. Trained and coached subjects in sleep hygiene which included how to properly get yourself ready for bed, diet,

environment.

UCLA Medical Center, Los Angeles, California January 1997 – June 1999

For more than half a century, UCLA Health System has provided the best in healthcare and the latest in medical

technology to the people of Los Angeles and throughout the world. Consistently receiving The Best in the West award

along with the honor of being ranked 5th best medical center in the United States.

Assistant Research Coordinator

Department of Nephrology & Cardiology

Promoted into Assistant Research Coordinator assisting in the coordination, process, and data collection for cardiology

research. Worked directly with physician who was conducting CME lectures on cardiology, specifically cholesterol and

blood pressure. Coordinated and recruited subjects for studies, maintained date retention, took patient vitals, drew

patient’s blood, and took medical history.

Dr. Jay N. Schapira & Dr. John G. Harold, June 1986 – September 1995

Cedars Sinai Medical Towers Los Angeles, California

Jay N. Schapira, MD is a cardiologist in the Division of Cardiology at the Cedars Sinai Heart Institute. He also is a

Clinical Professor of Medicine at the David Geffen School of Medicine at the University of California, Los Angeles

(UCLA). He is board certified in internal medicine and cardiovascular diseases. Dr. John G. Harold is a practicing

physician specializing in Cardiology, Internal Medicine, Critical Care Medicine and Geriatrics. From 2004 – 2006, he was

Chief of Staff at Cedars Sinai Medical Center.

Medical Coordinator & Back Office Assistant

Department of Cardiology& Internal Medicine

Closely worked with world renowned cardiologists and internal medicine physicians assisting them with patient’s medical

history, progress notes and reports, vitals, EKG, Treadmill, and Stress Echo test, Holter monitor, Pacemaker check, Heart Rate

Variability, Phlebotomy, X rays, diet program supervision, Pharmacotherapy. Assisting in office small surgical procedures;

scheduling office visits and outpatient procedures. Insurance exams for executive Insurance policies.

Dr. Richard Gold & Dr. Phil Levine, May 1985 – June 1986

Cedars Sinai Medical Towers Los Angeles, California

Medical Coordinator & Back Office Assistant

Department of Cardiology& Internal Medicine

Closely worked with world renowned cardiologists and internal medicine physicians assisting them with patient’s medical

history, progress notes and reports, vitals, EKG, Treadmill, Holter monitor, Phlebotomy, X rays, diet program supervision,

scheduling office visits and outpatient procedures.

November 1978 –

May 1985

Coordinator and Back Office Assistant in Medical Offices specializing in Internal Medicine, Cardiology,

Endocrinology, Oncology, Insurance Policies Exams, Obstetrics& Gynecology in Los Angeles and Chicago

Vilnius Red Cross Medical Center, October 1976 – May 1977

Vilnius Lithuania

Nurse Assistant

Emergency Room

Education & Certifications and Volunteering

Bachelors of Science, Nursing

Vilnius Specialized Medical College, Vilnius, Lithuania

• Graduated with Honors

Certificate of Completion Clinical Research Professional Orientation

Cedars Sinai Medical Center, Los Angeles, California

CPR Certification

Cedars Sinai Medical Center, Los Angeles, California

Good Clinical Practice & Best Practices Managing Clinical Trials

Johnson & Johnson, USA

SOCRA Research Review of Clinical Research Professionals,

SOCRA, USA

Phlebotomy Certification

Boston Read Course, Long Beach, California

Volunteering

Cedars Sinai Medical Center, Los Angeles, California

• Mealtime Mates and Information desk floater at the surgical department

Horace Mann Elementary School, Beverly Hills, California

• Events and class room coordinator.

Certificates of Appreciation

AstraZeneca and Quintiles Transnational

GSK

Letters recommendations and references on request

Contact this candidate