Quality Assurance Medical

Lenuta Micsa, MD

Lansdale, PA

646-***-****

abjp7a@r.postjobfree.com

EDUCATION: University of Medicine and Pharmacy "GR T POPA", Iasi,

Romania

Medical Doctor

PROFESSIONAL

EXPERIENCE:

MERCK, North Wales, PA - Consultant

November 2009 to present

Global Trial Specialist

. Accountable for managing the Clinical Research Operations

(CROps) deliverables in preparation of Site Ready and for the

achievement of recruitment targets and achievement of major

milestones.

. In collaboration with the Patient Recruitment Specialist group

create and implement managed recruitment and retention plans to

ensure patient accrual targets are met according to established

timelines.

. Primary Point of Contact for the Regional Shared Service Center

Protocol Managers and subsidiary personnel for the

identification of study needs/issues. Communicate the status of

global study progress and mitigation strategies.

. Manage Country Allocation at the trial level through

collaboration with CDPM, PRS, M&SO and RODs. Create, gather and

present key background information and validation results to

support country allocation activities. In collaboration with

CROps Global Medical Organization (GMO) Management and Regional

Operations Directors, determines which countries will be

allocated each trial and the patient level commitment for those

countries.

. Coordinate the organization and facilitation of investigator /

monitors meetings

. Liaise effectively with cross functional groups in MRL

Development and other areas of CROps, including subsidiary staff

on all issues related to the execution of assigned global

clinical trials/programs worldwide clinical studies.

. Develop and present topics of an operational nature that help to

facilitate the conduct of clinical trials between Merck HQ,

field personnel, and investigational study site staff.

ASTRAZENECA, Wilmington, Delaware - Consultant

August 2007 to April 2009

Senior Clinical Research Scientist

. Responsible for operational aspects of global studies from study

start-up through database lock and study close-out activities.

Lead and/or participate in activities that ensure quality,

consistency and integration of study data to agreed time, cost

and quality objectives

. Establish and maintain interactions with Marketing Companies,

Clinical Research Organizations (CROs), Academic clinics and

investigational study sites, as appropriate, and external

service providers (Third Party Vendors) to identify and resolve

operational feasibility issues, facilitate study start-up

activities

. Review monitoring reports to ensure quality and resolution of

site related issues

. Monitor study conduct and progress, proactively identifying to

and resolving with the Study Leader, issues which may impact

delivery of the study to the necessary quality, timeline or

budget objectives

. Contribute to the planning and conduct of global

Investigator/Monitors WebEx and teleconference meetings

. Operational lead to clinical event committee, data safety

monitoring board

. SAE reporting process. Ensure the SAE case is complete in timely

manner. Review SAE case form for completeness, actively

obtaining additional information, and work with the investigator

to resolve outstanding issues

. Contribute to the development of other SD documents as

appropriate as well as any updates/amendments to those documents

. Implement globally agreed Study Delivery and Clinical

Development strategies including processes and use of technical

systems related to Study Delivery (IMPACT, secure website for

external users)

. Manage the collection of country specific agreements,

confidentiality agreements, clinical trial applications

. Support the Clinical Quality Assurance team in the development

of and implementation of audits and regulatory inspections

. Provide input into non-drug project work including training

activities, and development of procedures

CARDIOVASCULAR RESEARCH FOUNDATION affiliated with Columbia

University, New York, NY

September 2004 to August 2007

Clinical Research Associate

. Responsible for study site management with an emphasis on study

progress, case report form review, tracking serious adverse

events, and drug/device accountability in compliance with

ICH/GCP guidelines

. Ensure site regulatory files are maintained in compliance with

protocol and ICH/GCP

. Responsible for monitor on-site regulatory documents and case

report forms and perform monitoring-related activities for

designated trials

. Interact with site coordinators as primary project

representative regarding tracking of patient enrollment, case

report forms, and adverse events

. Collaborate with clinical trial monitors to ensure compliance of

studies to protocols, SOPs, ICH/GCP guidelines and regulations

. Coordinate the Clinical Events Committee (CEC) meetings

. Review and write summaries for SAE/AE by compiling related

source documents from sites and case report forms for

presentation of clinical case summaries to Clinical Events

Committee (CEC) for adjudication

. Design case report forms, manual of operations, and informed

consent for multiple trials

. Validate data and generate case report queries, and clarify

and/or obtain changes to data as appropriate

. Develop baseline parameters and edit check specifications and

subject tracking systems

. Provide guidance and training for junior-level CRAs

. Function as Project Team Lead

. Prepare interim reports to FDA

MOUNT SINAI SCHOOL OF MEDICINE, DEPARTMENT OF NEURO-AIDS, New York,

New York

September 2002 to September 2004

Clinical Research Coordinator

. Coordinated grant funded research and industry sponsored

clinical trials

. Conferred with study participants to explain purpose of studies,

obtained informed consent, explained diagnostic procedures and

treatment, study participants follow-up

. Initiated and maintained regulatory documents, ensuring

compliance with protocol guidelines and requirements of

regulatory agencies

. Collaborated with clinical trial monitors to ensure compliance

of studies to protocols, SOPs, ICH/GCP guidelines and

regulations

. Collected data from patient charts, medical records, interviews,

diagnostic tests and other sources, evaluated and interpreted

collected data

. Provided Quantitative Sensory Testing (QST)

CENTRAL PARKING SYSTEMS, New York, New York

March 2001 to November 2003

Office Manager

. Managed income for NYC Department of Transportation (DOT)

Operations

. Provided weekly and monthly activity reports in accordance with

NYC DOT and Central Parking Systems guidelines

. Overseeing finances for special events

PRIVATE PRACTICE, Husi, Romania

June 2000 to January 2001

General/Family Physician

. Examined, diagnosed, treated and, where required, referred

patients to specialists, issued prescriptions Periodic

immunizations, gynecological examinations, pregnancy monitoring

were also performed

. Provided voluntary medical services to underserved medical areas

in Romania

UNIVERSITY OF MEDICINE AND PHARMACY TIRGU MURES, UNIVERSITY'S CLINICAL

HOSPITAL, Tirgu Mures, Romania

March 1997 to June 2000

Resident Physician

. Residency rotations included: Cardiology, Surgery, Hepathology,

Neurology, Dermatology, Diabetes and Metabolic Diseases,

Obstetrics and Gynecology, Infectious Diseases, Pediatric

Medicine and Emergency Medicine

TRAINING:

. USMLE (United States Medical Licensing Examination) Step

2 CSA, May 2007

. USMLE Step 2 CK (Clinical Knowledge), September 2006

. USMLE Step 1, December 2005

. HIPAA Training at Mount Sinai School of Medicine

. Education on the Protection of Human Subjects in

Research

. Mount Sinai School of Medicine, Institutional Review

Board Coordinator Training

CERTIFICATIONS: Certificate of Completion for Principles of ICH/GCP

PUBLICATIONS &

PRESENTATIONS:

. American Journal of Cardiology 2006; 98 (8) Suppl 1: 156,

Smaller vessel size predicts restenosis and stent thrombosis in

patients treated with the sirolimus-eluting BX VelocityTM stent:

pooled analysis from 8 trials, Pucelikova T, Nikolsky E,

Solinas E, Sulaiman R, Kesanakurthy V, Micsa L, Banu D, Fahy M,

Veeramacheni V, Leon MB, Mehran R, Publication Date, 2006

. Transcatheter Cardiovascular Therapeutics, Lower Body Mass Index

is a risk Factor for Hemorrhagic Complications Following

Percutaneous Coronary Interventions: Analysis From the REPLACE-

2 Trial, Eugenia Nikolsky, Michael A Lincoff, Roxana Mehran,

John A Bittl, Robert A Harrington, Hitinfrt Gurm, Lenuta Micsa,

Vijaya Kesanakurthy, Yingo Na, Tayo Addo, Susheel Kodali, Greg W

Stone, Publication Date, June 2005

. Current Neurology and Neuroscience Reports 2004, Neuromuscular

complications in HIV, Verma S, Micsa E Estanislao L, Simpson D,

Publication Date: 1/2004, Volume: 4, Pages: 62-67n HIV, Verma S,

Micsa E Estanislao L, Simpson D, Publication Date, January 2004,

Volume: 4, Pages: 62-67ysician, 1993

. Diploma Thesis: Depressive Syndrome - Diagnosis and Treatment

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