Medical Clinical Research
Resume:
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