Macka Barry, MD/ MSc

OBJECTIVE

Looking for a Clinical Research / Drug Safety/ Medical Science

position that utilizes my current Medical and Clinical Research skills and

experience

PROFILE

. Clinical research coordinator at a Clinical Research Facility in GA

with trials sponsored by Pfizer, Otsuka, Boehringer Ingelheim,

Eisai

. Medical professional with over 16 years clinical experience

. Self-motivated ability to work independently and effectively across

diverse functional areas with years of clinical experience.

. Fluent in, French, English and Chinese mandarin, excellent oral and

written communication.

EDUCATION

. Master of Science Molecular and Cell Biology - Quinnipiac University,

Hamden, Connecticut May 2011

. Master of Science Medicine Surgery-Urology-Fudan University Graduate

School of Medicine, Shanghai, China June 2004

. MD (Bachelor of Surgery and Bachelor of Medicine) - Shanghai Medical

University, Shanghai, China June 1993

. Clinical Research Associate certificate - Norton training Institute.

Lexington South Carolina, April 2012

TECHNICAL SKILL and TRAINING

. Great depth of Knowledge of ICH-GCP guidelines and FDA regulation

. Familiar with investigator Brochure, electronic submission

.Experienced with clinical case study up and running

. Familiar with writing and reviewing clinical documents

. Excellent knowledge of data base entry (Oracle INF, Rave Medidata, OC-

RDC, RDC)

. Detailed Knowledge of regulatory requirements/guideline for adverse

event (AE) and (SAE) reporting. Familiar with SAE reporting, clinical

drug safety and pharmacology principle and application. Familiar with

Impala, IcoPhone, ClinPhone, Exco Intouch...

. Experienced with MedDRA spreadsheets, and Statistic application SPSS

. Familiar with retrieval and use of medical literature

. Knowledge of Microsoft (word, excel, power point, Internet access,

outlook)

. Ability to work independently; to handle a variety of tasks

simultaneously and effectively

PROFESSIONAL EXPERIENCE

Clinical Research Coordinator Medical Research & Health Education

Foundation Inc.

07/2012 to present

. Provide support and coordination for drug studies that involve

pharmaceutical industry (Pfizer, Eisai, Otsuka, Boehringer Ingelheim

sponsored phase II, III IV clinical trials. Verify subject

eligibility. Prepare documentation for submission for review by the

IRB. Submit and maintain study data and ensure compliance with study

protocols. Respond to queries by providing narrative descriptions.

Provide SAE reporting to the safety teams and ensure compliance with

clinical drug safety. Review medical content and clinical relevance of

medical records related to patient eligibility. Ensure accurate

progress of clinical studies from approval stages through study

completion and post study closure. Work closely with CRA during site

visits.

Teacher at the Gee's training career center Woodbridge

VA 01/2012-07/2012

. Teaching Anatomy, Physiology, Phlebotomy to Allied health students.

Norton training Institute; Norton Audit Inc. Lexington South Carolina

04/2012

. Clinical research monitoring, GCP/ICH, 21 CFR, FDA regulation.

. Adverse events and effect reporting

. Audit skills for monitor, Investigator qualification visit, interim

visits, close-out visits

. Detailed clinical trial phases study.

Graduate Student at Quinnipiac University, Hamden, Connecticut

01/2010- 05/2011

Master of Science Molecular and Cell Biology

. Critical review of research papers, focus in summarizing, critiquing,

reporting and class discussion. Use of Bioinformatics in case study.

. Collection, documentation, entry, analysis and interpretation and

Statistical analysis of data. Writing and reviewing clinical

documents.

. Clinical case study and report including adverse event of drug

. Drug manufacturing: translated basic research findings into new drugs

. Worked constructively in group to generate data and an oral power

point report.

Referent surgeon with Doctors without Borders New York/Gore, Chad

05/2008-01/2010

. Performed Surgical and medical treatment of diseases in less developed

countries.

. Taught medical concept and practice procedures to local health care

providers

. Performed data entry, data analysis using electronic data capture,

excel software

. Performed informed consents and medical record according to ICH-GCP

guidelines

. Monitored and managed all employees (26) at the Department of Surgery

and Maternity.

. Performed clinical report of all patients seen at the establishment

according to MSF (Doctors without Borders) recommendations and

European regulations and guidance.

Joined Doctors without borders in August 2007 and started the New

York/ Gore, Chad

Project in May of 2008.

PHYSICIAN-Urologist and Research Coordinator at the Department of

Urology-

Andrology Ignace Deen Teaching Hospital, Conakry, Guinea

12/2004-07/2007

. Performed surgical and nonsurgical treatment of all urological

diseases seen at the Department of Urology-Andrology, includes cancer

patients intensive therapy.

. Monitored and managed all prostate cancer patients at the Department

focusing in informed consents of the treatment, recording, data

generating and reporting of all adverse events of the drugs to the

Department, included a summary of a final report according to ICH-GCP

regulation and guidelines

. Participated in clinical case study and clinical research study in

compliance of SOPs

. Taught urological concepts to medical students at the Medical

University Guinea

. Coordinated medical students in their theses elaboration and clinical

research.

Graduate fellow and Research Assistant at the Department of Surgery-

Urology

Hua Shang Hospital, Shanghai, China

09/2001-06/2004

. Participated and performed surgical and non surgical treatment of

urological diseases.

. Participated in clinical trial study of renal carcinomas patients,

includes, patient selection, data entry, medical record, drug

(Interleukin-2) use, adverse events summary and report according to

standard operating procedure (SOPs) and ICH-GCP guidelines.

. Performed review protocol compliance, focusing on inclusion and

exclusion requirements.

. Performed Laboratory Animal Medicine with tissue harvesting, tumor

implant and animal handling, Infectious disease and Anti-biotherapy,

Medicine statistic and Experimental practice of Microsurgery training

. Wrote clinical research papers in bladder tumor

. Participated to the annual Shanghai's congress of Urology in China

2002 and 2003.

LIST OF THERAPEUTIC EXPERIENCE

. Urology and Oncology, metastatic pain, Intensive care unit Prostate

cancer, bladder cancer, renal carcinoma, urology infectious diseases,

etc...

. Immune diseases, Nephrology, renal failure, dialysis and renal

transplantation

. Research: Neuroscience, cardio-vascular diseases and diabetes.

Membership: ACRP

Clinical experience:

Clinical research coordinator: Boehringer Ingelheim 1245.25 BI 10773

Diabetic with Increase Cardiovascular Risk study.

Clinical research coordinator: Pfizer 3133K1-3000 Bapineuzumab Alzheimer's

disease treatment trial

Clinical research coordinator: Jansen Alzheimer Immunology ELN 115727- 351

Bapineuzumab ICARA Alzheimer 's Disease treatment trials

Clinical research coordinator: Pfizer A0081275 Pregabalin in the treatment

of Fibromyalgia with concurrent antidepressant therapy for depression

study.

Clinical research coordinator: Eisai BAN 2401-G00-201; BAN 2401 Safety,

Tolerability and efficacy in Subject with Early Alzheimer's Disease.

Clinical research coordinator: ELAN ELDN005-AG-201; ELDN005 for the

treatment of agitation and Aggression in patient with Moderate to severe

Alzheimer 's Disease.

Clinical research coordinator: Otsuka 31-12-293, Aripiprazole in Children

and Adolescent with Tourette's Disorder.

Clinical research coordinator: Pfizer A0081180, Pregabalin in the treatment

of adolescents with Fibromyalgia

Clinical research coordinator: Daiichi Sankyo DS5565-A-U201, DS-5565 for

treatment of Neuropathic pain associated with diabetic peripheral

Neuropathy.

Contact this candidate