Macka Barry 703-565-8758 mackabarry@hotmail.com.

SUMMARY:Certified Clinical Research Professional with over 5 years of experience in the field of clinical research. Medical background working over 16 years as a physician (outpatient and inpatient) in different therapeutic areas. Dedicated to quality with continuous improvement. Excellent oral and written communication skills.

HIGHLIGHTS: ICH-GCP guideline, FDA regulation 21CFR part 11 and HIPPA guidelines. MedDra and WHO drug dictionaries SAE reporting, SAE Reconciliation. Medical record extraction, Triage Case Processing, Coding and Narratives. CIOMS line listing, Signal detection RMP & REMS, ICSRs, SUSAR & PSURs. Protocol, Investigational Brochure, Medical data review, IND safety reports Oracle Argus safety database, Microsoft SOP, TMF, GxPs knowledge. Clinical data monitoring, Site management & Coordination, Patient safety Writing and editing Clinical papers, Clinical Trial design, Rx-to OTC switch.

EXPERIENCE:Medical Research & Health Education Foundation Columbus GA July 2012 to presentSenior Clinical Research Coordinator

Conducted site level clinical studies. Responsible for site management and general compliance. Prepared all external and internal documentation for assigned trials (phase II to IV). Performed data collection, medical review, data entry & queries resolution & reconciliation. Reviewed study patient AEs, prepared drug AE report, including case narrative. Submitted site regulatory documents and reported drug AEs & SAEs to safety team.

Qtech Solutions Inc. Somerset NJ June 2014 to May 2015Drug Safety Associate/Clinical Scientist Internship

Extracted relevant Medical Data and created Individual case safety reports in the safety database. Reviewed cases for medical soundness, evaluated causal relationships, provided medical comments and wrote

and edited case narratives. Resolved conflicted comments among reviewers. Provided medical input for ad-hoc queries as requested. Performed Rx-to-OTC Switch transfer of proven prescription drugs (Rx) to nonprescription, OTC status. Performed Pharmacovigilance reports including Individual case safety report (ICSRs), Suspected Unexpected

Serious Adverse Reactions (SUSARs), Periodic Reports (PRs), and Periodic safety Update Reports (PSURs). Reviewed ICSR for assessment, classification and prioritization. Created case in safety data base. Performed and reviewed individual case safety reports in safety database for accuracy. Consistently used Drug Safety Database (Oracle Argus) for action items, contact log and work list for

communication and follow up requests. Performed coding of serious and non-serious adverse events using Med DRA terminology. Provided medical guidance and opinion to non-medical personnel and Drug safety team. Performed in-depth concise written narrative of serious and non-serious adverse events. Reconciled serious adverse events reported in both clinical data base and safety database.

Gee’s training career center Woodbridge VA January 2012 to July 2012Teacher of Basic Medicine

Taught Anatomy, Physiology, Phlebotomy to Allied health students.

Norton training Institute-Norton Audit Inc. Lexington SC April 2012Clinical Research Associate

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. Clinic trial design. Protocol related training.

Quinnipiac University, Hamden, CT January 2010 to May2011Molecular and Cell Biology Graduate Student - MSc.

Conducted critical review of research papers, summarizing, analyzing and interpreting data. Drug manufacturing: translated basic research findings into new drugs. Worked constructively in group to generate data and an oral power point report. Performed analytical problem solving and interpretation of medical data. Wrote and edited clinical paper.

Doctors without Borders New York/Gore, Chad May 2008 to January 2010Referent Surgeon

Performed surgical and medical treatment of diseases in less developed countries. Taught medical concept and practice procedures to local health care providers. 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, Project May 2008

Ignace Deen Teaching Hospital, Conakry, Guinea December 2004 to July 2007Physician-Urologist and Research Coordinator

Performed surgical and nonsurgical treatment of all urological diseases seen at the Department of Urology- Andrology, including cancer patients intensive therapy.

Monitored and managed all prostate cancer patients at the Department 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 thesis elaboration and clinical research.

Hua Shang Hospital, Shanghai, China September 2001 to June 2004Graduate fellow and Research Assistant

Participated and performed surgical and non-surgical treatment of urological diseases. Participated in clinical trial study of renal carcinomas patients, Performed medical review protocol compliance,

focusing on inclusion and exclusion requirements. Wrote clinical research papers on bladder tumor. Participated in the annual Shanghai’s congress of Urology in China 2002 and 2003.

EDUCATION:Quinnipiac University, Hamden, Connecticut

Master of Science Molecular and Cell Biology Fudan University Graduate School of Medicine, Shanghai, China

Master of Science Medicine Surgery-Urology Shanghai Medical University, Shanghai, China

MD (Bachelor of Surgery and Bachelor of Medicine) New Jersey Qtech Solution Inc.

Drug Safety Associate/ Pharmacovigilance Certification - May 2015South Carolina Norton Training Institute

Clinical Research Associate Certification - Apr 2012Online training Coursera

Data Management for Clinical Research Certification - 2014

LIST OF THERAPEUTIC EXPERIENCE:Urology: Prostate cancer, bladder cancer, renal carcinoma, urology infectious diseasesOncology, metastatic pain, Intensive care unit, etc…Immune diseases, Nephrology, renal failure, dialysis and renal transplantationResearch: Neuroscience Alzheimer’s disease study, cardio-vascular diseases and diabetes.Membership: ACRP.