Medical Clinical Research
Resume:
Lana L. Levi
*********@*****.***
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
*********@*****.*** 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